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FDA 510(k)

GLUCOSE DETERM. KIT

K-Number: K781307 · 1978-08-31

ApplicantAnalytical & Research Chemicals, Inc.
Decision Date1978-08-31
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE DETERM. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Analytical & Research Chemicals, Inc.. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781307. 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 DETERM. KIT?

GLUCOSE DETERM. KIT is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Analytical & Research Chemicals, Inc.. The 510(k) number is K781307.

When did GLUCOSE DETERM. KIT receive FDA 510(k) clearance?

GLUCOSE DETERM. KIT received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781307.

Who is the listed applicant for GLUCOSE DETERM. KIT?

The FDA 510(k) record lists Analytical & Research Chemicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOSE DETERM. KIT?

The FDA product code for GLUCOSE DETERM. KIT is CGA.

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Other records listing Analytical & Research Chemicals, 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.

K823784ENZYMATIC CHOLESTEROL (COLORIMETRICK823786ALKALINE PHOSPHATASEK823806DIRECT CREATININE PROCEDUREK781441BCG ALBUMIN REAGETK781460CHLORIDE REAGENTK781324ALP TEST

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Related Devices (Code: CGA)

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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