FDA 510(k)

GLUCOSE ENZYMATIC REAGENT SET

K-Number: K841055 · 1984-05-01

Decision Date1984-05-01

Product CodeCGA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GLUCOSE ENZYMATIC REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties, Inc.. It received FDA 510(k) clearance on 1984-05-01 under 510(k) number K841055. 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 ENZYMATIC REAGENT SET?

GLUCOSE ENZYMATIC REAGENT SET is a medical device that received FDA 510(k) clearance on 1984-05-01. The listed applicant is Medical Specialties, Inc.. The 510(k) number is K841055.

When did GLUCOSE ENZYMATIC REAGENT SET receive FDA 510(k) clearance?

GLUCOSE ENZYMATIC REAGENT SET received FDA 510(k) clearance on 1984-05-01, under 510(k) number K841055.

Who is the listed applicant for GLUCOSE ENZYMATIC REAGENT SET?

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

What is the FDA product code for GLUCOSE ENZYMATIC REAGENT SET?

The FDA product code for GLUCOSE ENZYMATIC REAGENT SET is CGA.

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Official Source

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