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FDA 510(k)

GLYCOSYLATED HEMOGLOBIN KIT

K-Number: K801561 · 1980-08-12

ApplicantAmersham Corp.
Decision Date1980-08-12
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCOSYLATED HEMOGLOBIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1980-08-12 under 510(k) number K801561. 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 GLYCOSYLATED HEMOGLOBIN KIT?

GLYCOSYLATED HEMOGLOBIN KIT is a medical device that received FDA 510(k) clearance on 1980-08-12. The listed applicant is Amersham Corp.. The 510(k) number is K801561.

When did GLYCOSYLATED HEMOGLOBIN KIT receive FDA 510(k) clearance?

GLYCOSYLATED HEMOGLOBIN KIT received FDA 510(k) clearance on 1980-08-12, under 510(k) number K801561.

Who is the listed applicant for GLYCOSYLATED HEMOGLOBIN KIT?

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

What is the FDA product code for GLYCOSYLATED HEMOGLOBIN KIT?

The FDA product code for GLYCOSYLATED HEMOGLOBIN KIT 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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