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FDA 510(k)

GLUCOSE REAGENT, ENZYMATIC

K-Number: K770311 · 1977-03-30

ApplicantIcn Pharmaceuticals, Inc.
Decision Date1977-03-30
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE REAGENT, ENZYMATIC is the device name listed in this FDA 510(k) record. The listed applicant is Icn Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1977-03-30 under 510(k) number K770311. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE REAGENT, ENZYMATIC?

GLUCOSE REAGENT, ENZYMATIC is a medical device that received FDA 510(k) clearance on 1977-03-30. The listed applicant is Icn Pharmaceuticals, Inc.. The 510(k) number is K770311.

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

GLUCOSE REAGENT, ENZYMATIC received FDA 510(k) clearance on 1977-03-30, under 510(k) number K770311.

Who is the listed applicant for GLUCOSE REAGENT, ENZYMATIC?

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

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

The FDA product code for GLUCOSE REAGENT, ENZYMATIC is CFR.

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Related Devices (Code: CFR)

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.

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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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