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FDA 510(k)

MICROPROTEIN STANDARD KIT

K-Number: K974290 · 1997-12-19

ApplicantVerichem Laboratories, Inc.
Decision Date1997-12-19
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICROPROTEIN STANDARD KIT 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 1997-12-19 under 510(k) number K974290. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROPROTEIN STANDARD KIT?

MICROPROTEIN STANDARD KIT is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is Verichem Laboratories, Inc.. The 510(k) number is K974290.

When did MICROPROTEIN STANDARD KIT receive FDA 510(k) clearance?

MICROPROTEIN STANDARD KIT received FDA 510(k) clearance on 1997-12-19, under 510(k) number K974290.

Who is the listed applicant for MICROPROTEIN STANDARD KIT?

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 MICROPROTEIN STANDARD KIT?

The FDA product code for MICROPROTEIN STANDARD KIT is JIX.

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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, CHOLESK973345MATRIX PLUS MULTI-CALIBRATOR KITK972333AMMONIA/IRON STANDARD KITK924904HDL-CHOLESTEROL STANDARD, MODIFICATIONK912513ELECTROLYTE CONTROLK901113MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD

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Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

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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