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FDA 510(k)

GLUCOSE REAGENT-ENZYMATIC-COLOR 500

K-Number: K811074 · 1981-04-29

ApplicantReagents Applications, Inc.
Decision Date1981-04-29
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE REAGENT-ENZYMATIC-COLOR 500 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 1981-04-29 under 510(k) number K811074. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE REAGENT-ENZYMATIC-COLOR 500?

GLUCOSE REAGENT-ENZYMATIC-COLOR 500 is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K811074.

When did GLUCOSE REAGENT-ENZYMATIC-COLOR 500 receive FDA 510(k) clearance?

GLUCOSE REAGENT-ENZYMATIC-COLOR 500 received FDA 510(k) clearance on 1981-04-29, under 510(k) number K811074.

Who is the listed applicant for GLUCOSE REAGENT-ENZYMATIC-COLOR 500?

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 GLUCOSE REAGENT-ENZYMATIC-COLOR 500?

The FDA product code for GLUCOSE REAGENT-ENZYMATIC-COLOR 500 is CGA.

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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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