Search Results
Found 36 results
510(k) Data Aggregation
K Number
K042717Device Name
MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
Manufacturer
MEDICAL ANALYSIS SYSTEMS, INC.
Date Cleared
2004-11-05
(36 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ANALYSIS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for Hemoglobin A1c and methods listed in this package insert.
Device Description
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K Number
K041194Device Name
ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
Manufacturer
MEDICAL ANALYSIS SYSTEMS, INC.
Date Cleared
2004-08-16
(102 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ANALYSIS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ARCHITECT® Troponin-I Controls are for verification of the accuracy and precision of the ARCULLECT i2000gg System when used for the quantitative determination of cardiac Troponin-1 in human serum and plasma. Refer to the ARCHITECT STAT Troponin-1 reagent package insert for additional information.
Device Description
ARCHITECT STAT Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H
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K Number
K040880Device Name
MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
Manufacturer
MEDICAL ANALYSIS SYSTEMS, INC.
Date Cleared
2004-04-28
(23 days)
Product Code
JJY, JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ANALYSIS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAS® CardioImmune® TL is intended for use in the clinical laboratory as an assayed control scrum suitable for monitoring assay conditions in specific cardiac marker determinations. Include this product with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Device Description
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K Number
K032826Device Name
MAS PAR TDM
Manufacturer
MEDICAL ANALYSIS SYSTEMS, INC.
Date Cleared
2003-10-09
(29 days)
Product Code
DIF
Regulation Number
862.3280Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ANALYSIS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAS® PAR TDM is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include PAR TDM with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Device Description
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K Number
K032335Device Name
MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
Manufacturer
MEDICAL ANALYSIS SYSTEMS, INC.
Date Cleared
2003-08-19
(21 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ANALYSIS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAS® CardioImmune® TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include CardioImmune® TL with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
The MAS® CardioImmune® proBNP is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include CardioImmune® proBNP with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Device Description
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K Number
K031890Device Name
MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
Manufacturer
MEDICAL ANALYSIS SYSTEMS, INC.
Date Cleared
2003-07-16
(28 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ANALYSIS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MAS® Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Device Description
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K Number
K031392Device Name
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
Manufacturer
MEDICAL ANALYSIS SYSTEMS, INC.
Date Cleared
2003-07-01
(60 days)
Product Code
DKC
Regulation Number
862.3280Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ANALYSIS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MAS® Tox · Ammonia Control is intended for use in the clinical laboratory as quantitative controls for monitoring test procedures used to assay human serum and/or plasma specimens for alcohol, ammonia, acetaminophen and salicylate. Include Tox · Ammonia Control with patient serum or plasma specimens when assaying for any of the listed constituents. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Device Description
Not Found
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K Number
K031441Device Name
URICHEMTRAK LIQUID ASSAYED URINE CONTROL
Manufacturer
MEDICAL ANALYSIS SYSTEMS, INC.
Date Cleared
2003-07-01
(56 days)
Product Code
JJW
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ANALYSIS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MAS® UrichemTRAK Tri-Level control is intended for use in the clinical laboratory as consistent test samples of known concentration for monitoring assay conditions in many urine determinations. Include UrichemTRAK control with patient urine specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment.
Device Description
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K Number
K031364Device Name
MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3
Manufacturer
MEDICAL ANALYSIS SYSTEMS, INC.
Date Cleared
2003-05-30
(30 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ANALYSIS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAS® Cardiolmmune® proBNP is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include Cardiolmmune® proBNP with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Device Description
MAS® CardioImmune® proBNP Liquid Assayed Cardiac Marker Control Level 1, 2 and 3
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K Number
K030942Device Name
MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL
Manufacturer
MEDICAL ANALYSIS SYSTEMS, INC.
Date Cleared
2003-04-28
(33 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ANALYSIS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAS® chemTRAK® · H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include MAS® chemTRAK .. II with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges us a means of assuring consistent performance of reagent and instrument.
The DADE® Moni-Trol® • H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include DADE® Moni-Trolf · H with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
The OLYMPUS Chemistry Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Chemistry Control with patient serum specimens when assaying for any of the listed consititients. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Device Description
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