CORNING GLYCOSYLATED HEMOGLOBIN SET— 510(k) K791777

Name: FDA 510(k) clearance K791777
Creator: U.S. Food and Drug Administration
Published: 1979-11-13

Substantially Equivalent

Corning Medical & Scientific

FDA 510(k) clearance K791777 for CORNING GLYCOSYLATED HEMOGLOBIN SET, Substantially Equivalent on 1979-11-13. Applicant: Corning Medical & Scientific. Device class: 2.

Clearance details

Applicant: Corning Medical & Scientific
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1979-09-10
Decision date: 1979-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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