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FDA 510(k)

A-GENT GLYCOSYLATED HEMOGLOBIN

K-Number: K832775 · 1983-09-29

ApplicantAbbott Laboratories
Decision Date1983-09-29
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

A-GENT GLYCOSYLATED HEMOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832775. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-GENT GLYCOSYLATED HEMOGLOBIN?

A-GENT GLYCOSYLATED HEMOGLOBIN is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Abbott Laboratories. The 510(k) number is K832775.

When did A-GENT GLYCOSYLATED HEMOGLOBIN receive FDA 510(k) clearance?

A-GENT GLYCOSYLATED HEMOGLOBIN received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832775.

Who is the listed applicant for A-GENT GLYCOSYLATED HEMOGLOBIN?

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

What is the FDA product code for A-GENT GLYCOSYLATED HEMOGLOBIN?

The FDA product code for A-GENT GLYCOSYLATED HEMOGLOBIN is LCP.

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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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