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FDA 510(k)

GLUCOSE REAGENT

K-Number: K823537 · 1983-04-06

ApplicantAc Biochemical Laboratories, Inc.
Decision Date1983-04-06
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLUCOSE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Ac Biochemical Laboratories, Inc.. It received FDA 510(k) clearance on 1983-04-06 under 510(k) number K823537. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE REAGENT?

GLUCOSE REAGENT is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Ac Biochemical Laboratories, Inc.. The 510(k) number is K823537.

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

GLUCOSE REAGENT received FDA 510(k) clearance on 1983-04-06, under 510(k) number K823537.

Who is the listed applicant for GLUCOSE REAGENT?

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

What is the FDA product code for GLUCOSE REAGENT?

The FDA product code for GLUCOSE REAGENT is FMF.

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Other records listing Ac Biochemical Laboratories, 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.

K823500CHOLESTEROL REAGENTK822913URIC ACID REAGENT

Related Devices (Code: FMF)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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