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FDA 510(k)

GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY

K-Number: K822867 · 1982-12-03

ApplicantIsolab, Inc.
Decision Date1982-12-03
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1982-12-03 under 510(k) number K822867. 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 GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY?

GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Isolab, Inc.. The 510(k) number is K822867.

When did GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY receive FDA 510(k) clearance?

GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY received FDA 510(k) clearance on 1982-12-03, under 510(k) number K822867.

Who is the listed applicant for GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY?

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

What is the FDA product code for GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY?

The FDA product code for GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY is LCP.

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Related Devices (Code: LCP)

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

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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