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Found 4 results
510(k) Data Aggregation
K Number
K112834Device Name
MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
Manufacturer
Date Cleared
2012-03-28
(182 days)
Product Code
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
VERICHEM LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Carbon Dioxide Standard Kit is an in vitro diagnostic product intended for<br>calibration or calibration verification of carbon dioxide test systems.
The Urine Chemistry Standard Kit is an in vitro diagnostic product intended for<br>calibration or calibration verification of clinical chemistry test systems.
The Urine Uric Acid Standard Kit is an in vitro diagnostic product intended for<br>calibration or calibration verification of clinical chemistry test systems.
The Electrolyte Standard Kit is an in vitro diagnostic product intended for calibration or<br>calibration verification of serum electrolyte test systems.
The Cholesterol Standard Kit is an in vitro diagnostic product intended for calibration<br>or calibration verification of clinical chemistry test systems.
The Uric Acid Standard Kit is an in vitro diagnostic product intended for calibration or<br>calibration verification of clinical chemistry test systems.
The ISE Standard Kit is an in vitro diagnostic product intended for calibration or<br>calibration verification of clinical chemistry test systems.
The ISE Standard (S4) is an in vitro diagnostic product intended for calibration or<br>calibration verification of clinical chemistry test systems.
The Multi-Chemistry Standard Kit is an in vitro diagnostic product intended for<br>calibration or calibration verification of clinical chemistry test systems :
Device Description
All calibrator materials included in this submission are aqueous, primary standards containing known amounts of each component for in vitro diagnostic use. Standardization is achieved by gravimetric procedure. Verification is performed using available NIST Standard Reference materials.
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K Number
K974290Device Name
MICROPROTEIN STANDARD KIT
Manufacturer
Date Cleared
1997-12-19
(35 days)
Product Code
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
VERICHEM LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Microprotein Standard Kit is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
Device Description
MICROPROTEIN STANDARD KIT
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K Number
K973345Device Name
MATRIX PLUS MULTI-CALIBRATOR KIT
Manufacturer
Date Cleared
1997-10-29
(54 days)
Product Code
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
VERICHEM LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MATRIX PLUS Multi-calibrator Kit is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
Device Description
MATRIX PLUS MULTI-CALIBRATOR KIT
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K Number
K972333Device Name
AMMONIA/IRON STANDARD KIT
Manufacturer
Date Cleared
1997-07-23
(30 days)
Product Code
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
VERICHEM LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ammonia/Iron Standard Kit is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
Device Description
Not Found
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