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510(k) Data Aggregation
K Number
K012243Device Name
MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL
Manufacturer
Date Cleared
2001-08-20
(34 days)
Product Code
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
HEMATRONIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MCC™ URICHECK™ from HEMATRONIX, INC. is a synthetic matrix based assayed liquid urine multi-constituent control intended to monitor the precision and accuracy of instrument used in the clinical laboratory environment. MCC™ URICHECK™ is intended to monitor the precision and accuracy of instrument used in the methods when run as a patient sample and is ready to use. Expected ranges for the chemical and physical properties of MCC™ URICHECK™ have been established for monitoring or quantitative "constituents" used in routine clinical chemistry analysis.
Device Description
MCC™ URICHECK™ Assayed Liquid Urine Multi-Constituent Control is a synthetic matrix based assayed liquid urine multi-constituent control.
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K Number
K993496Device Name
RETIC-QUINOX
Manufacturer
Date Cleared
1999-11-30
(46 days)
Product Code
Regulation Number
864.8625Why did this record match?
Applicant Name (Manufacturer) :
HEMATRONIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Retic-Quinox is a whole blood reference control material designed to monitor the accuracy and precision of Coulter instruments equipped with reticulocye measuring capabilities using VCS technology.
Device Description
Retic-Quinox is a reference control material designed to monitor the accuracy and precision of Coulter instruments capable of performing reticulocyte counts.
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K Number
K972710Device Name
QUANTIFY(901)
Manufacturer
Date Cleared
1997-08-15
(25 days)
Product Code
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
HEMATRONIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Hematronix qUAntify™ Control System is a liquid, ready-to-use, urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals. Controls evaluate the quality of day-to-day test performance. The qUAntify Control System is used to determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick testing. Alternative tests such as the Glucose (Clinites), Bilirubin (Ictotest) and Ketone (Acetest) are also assayed. This control can be used to quality control the specified urine hCG tests. Two distinct levels are included to verify the recovery of normal and elevated patient values.
Device Description
The Hematronix qUAntify™ Control System is a liquid, ready-to-use, urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals.
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K Number
K960471Device Name
TRI-COUNT 20
Manufacturer
Date Cleared
1996-03-20
(48 days)
Product Code
Regulation Number
864.8625Why did this record match?
Applicant Name (Manufacturer) :
HEMATRONIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K960005Device Name
TRI-COURT 20-T
Manufacturer
Date Cleared
1996-03-19
(77 days)
Product Code
Regulation Number
864.8625Why did this record match?
Applicant Name (Manufacturer) :
HEMATRONIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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