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FDA 510(k)

APEC GLUCOSE ANALYZER

K-Number: K931196 · 1993-12-07

ApplicantApec, Inc.
Decision Date1993-12-07
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APEC GLUCOSE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Apec, Inc.. It received FDA 510(k) clearance on 1993-12-07 under 510(k) number K931196. 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 APEC GLUCOSE ANALYZER?

APEC GLUCOSE ANALYZER is a medical device that received FDA 510(k) clearance on 1993-12-07. The listed applicant is Apec, Inc.. The 510(k) number is K931196.

When did APEC GLUCOSE ANALYZER receive FDA 510(k) clearance?

APEC GLUCOSE ANALYZER received FDA 510(k) clearance on 1993-12-07, under 510(k) number K931196.

Who is the listed applicant for APEC GLUCOSE ANALYZER?

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

What is the FDA product code for APEC GLUCOSE ANALYZER?

The FDA product code for APEC GLUCOSE ANALYZER 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.

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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