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FDA 510(k)

GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ

K-Number: K761154 · 1976-12-09

Decision Date1976-12-09
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomedical Methods, Inc.. It received FDA 510(k) clearance on 1976-12-09 under 510(k) number K761154. 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 REAG FOR BECKMAN ANALYZ?

GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ is a medical device that received FDA 510(k) clearance on 1976-12-09. The listed applicant is Advanced Biomedical Methods, Inc.. The 510(k) number is K761154.

When did GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ receive FDA 510(k) clearance?

GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ received FDA 510(k) clearance on 1976-12-09, under 510(k) number K761154.

Who is the listed applicant for GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ?

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

What is the FDA product code for GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ?

The FDA product code for GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ is CGA.

Related Clinical Trials

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.

Other records listing Advanced Biomedical Methods, 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)

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.

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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