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FDA 510(k)

GLUCOSE ENZYME-COLOR REAGENT SET

K-Number: K813412 · 1981-12-31

ApplicantDiagnostic Specialties
Decision Date1981-12-31
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE ENZYME-COLOR REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Specialties. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813412. 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 ENZYME-COLOR REAGENT SET?

GLUCOSE ENZYME-COLOR REAGENT SET is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Diagnostic Specialties. The 510(k) number is K813412.

When did GLUCOSE ENZYME-COLOR REAGENT SET receive FDA 510(k) clearance?

GLUCOSE ENZYME-COLOR REAGENT SET received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813412.

Who is the listed applicant for GLUCOSE ENZYME-COLOR REAGENT SET?

The FDA 510(k) record lists Diagnostic Specialties as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOSE ENZYME-COLOR REAGENT SET?

The FDA product code for GLUCOSE ENZYME-COLOR REAGENT SET is CGA.

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Related Devices (Code: 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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