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FDA 510(k)

GERMCO TEST R GLUCOSE TEST KIT

K-Number: K810567 · 1981-03-13

ApplicantFermco Biochemics, Inc.
Decision Date1981-03-13
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GERMCO TEST R GLUCOSE TEST KIT 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 1981-03-13 under 510(k) number K810567. 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 GERMCO TEST R GLUCOSE TEST KIT?

GERMCO TEST R GLUCOSE TEST KIT is a medical device that received FDA 510(k) clearance on 1981-03-13. The listed applicant is Fermco Biochemics, Inc.. The 510(k) number is K810567.

When did GERMCO TEST R GLUCOSE TEST KIT receive FDA 510(k) clearance?

GERMCO TEST R GLUCOSE TEST KIT received FDA 510(k) clearance on 1981-03-13, under 510(k) number K810567.

Who is the listed applicant for GERMCO TEST R GLUCOSE TEST KIT?

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 GERMCO TEST R GLUCOSE TEST KIT?

The FDA product code for GERMCO TEST R GLUCOSE TEST KIT 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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