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FDA 510(k)

RAICHEM & GT REAGENT

K-Number: K823090 · 1982-11-22

ApplicantReagents Applications, Inc.
Decision Date1982-11-22
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM & GT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Reagents Applications, Inc.. It received FDA 510(k) clearance on 1982-11-22 under 510(k) number K823090. The device is classified under product code JPZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAICHEM & GT REAGENT?

RAICHEM & GT REAGENT is a medical device that received FDA 510(k) clearance on 1982-11-22. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K823090.

When did RAICHEM & GT REAGENT receive FDA 510(k) clearance?

RAICHEM & GT REAGENT received FDA 510(k) clearance on 1982-11-22, under 510(k) number K823090.

Who is the listed applicant for RAICHEM & GT REAGENT?

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

What is the FDA product code for RAICHEM & GT REAGENT?

The FDA product code for RAICHEM & GT REAGENT is JPZ.

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Other records listing Reagents Applications, Inc. as applicant

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Related Devices (Code: JPZ)

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.

K020486CARESIDE GGTCareside, Inc.K961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREData Medical Associates, Inc.K923509GAMMA-GTRandox Laboratories, Ltd.K923091KING DIAGNOSTICS GAMMA GT REAGENTKing Diagnostics, Inc.K905618GGT REAGENTAmresco, Inc.K903304ROCHE COBAS READY GGT REAGENTRoche Diagnostic Systems, 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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