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FDA 510(k)

GLUCOSE TRINDER, ENZYMATIC

K-Number: K770317 · 1977-03-30

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

Device Summary

GLUCOSE TRINDER, 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 K770317. 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 TRINDER, ENZYMATIC?

GLUCOSE TRINDER, 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 K770317.

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

GLUCOSE TRINDER, ENZYMATIC received FDA 510(k) clearance on 1977-03-30, under 510(k) number K770317.

Who is the listed applicant for GLUCOSE TRINDER, 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 TRINDER, ENZYMATIC?

The FDA product code for GLUCOSE TRINDER, ENZYMATIC 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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