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FDA 510(k)

GLUCOSE OXIDASE REAGENT

K-Number: K781945 · 1979-01-17

ApplicantFermco Biochemics, Inc.
Decision Date1979-01-17
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE OXIDASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Fermco Biochemics, Inc.. It received FDA 510(k) clearance on 1979-01-17 under 510(k) number K781945. 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 OXIDASE REAGENT?

GLUCOSE OXIDASE REAGENT is a medical device that received FDA 510(k) clearance on 1979-01-17. The listed applicant is Fermco Biochemics, Inc.. The 510(k) number is K781945.

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

GLUCOSE OXIDASE REAGENT received FDA 510(k) clearance on 1979-01-17, under 510(k) number K781945.

Who is the listed applicant for GLUCOSE OXIDASE REAGENT?

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

What is the FDA product code for GLUCOSE OXIDASE REAGENT?

The FDA product code for GLUCOSE OXIDASE REAGENT is CGA.

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Other records listing Fermco Biochemics, Inc. as applicant

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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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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