QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL— 510(k) K820630

Name: FDA 510(k) clearance K820630
Creator: U.S. Food and Drug Administration
Published: 1982-06-25

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K820630 for QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL, Substantially Equivalent on 1982-06-25. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code JPC
Device class: Class 2
Regulation: 21 CFR 864.7455
Advisory panel: Hematology
Date received: 1982-03-08
Decision date: 1982-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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