GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY— 510(k) K822867

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K822867 for GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY, Substantially Equivalent on 1982-12-03. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1982-09-27
Decision date: 1982-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.