GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT— 510(k) K864643

Name: FDA 510(k) clearance K864643
Creator: U.S. Food and Drug Administration
Published: 1987-04-28

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K864643 for GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT, Substantially Equivalent on 1987-04-28. Applicant: Pacific Hemostasis. Device class: 2.

Clearance details

Applicant: Pacific Hemostasis
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1986-11-26
Decision date: 1987-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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