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FDA 510(k)

MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD

K-Number: K901113 · 1990-03-29

ApplicantVerichem Laboratories, Inc.
Decision Date1990-03-29
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD is the device name listed in this FDA 510(k) record. The listed applicant is Verichem Laboratories, Inc.. It received FDA 510(k) clearance on 1990-03-29 under 510(k) number K901113. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD?

MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD is a medical device that received FDA 510(k) clearance on 1990-03-29. The listed applicant is Verichem Laboratories, Inc.. The 510(k) number is K901113.

When did MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD receive FDA 510(k) clearance?

MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD received FDA 510(k) clearance on 1990-03-29, under 510(k) number K901113.

Who is the listed applicant for MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD?

The FDA 510(k) record lists Verichem Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD?

The FDA product code for MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD is JIS.

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Other records listing Verichem Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112834MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLESK974290MICROPROTEIN STANDARD KITK973345MATRIX PLUS MULTI-CALIBRATOR KITK972333AMMONIA/IRON STANDARD KITK924904HDL-CHOLESTEROL STANDARD, MODIFICATIONK912513ELECTROLYTE CONTROL

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Related Devices (Code: JIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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