DADE FACTOR ASSAY REFERENCE PLASMA— 510(k) K820085

Name: FDA 510(k) clearance K820085
Creator: U.S. Food and Drug Administration
Published: 1982-02-23

Substantially Equivalent

American Dade

FDA 510(k) clearance K820085 for DADE FACTOR ASSAY REFERENCE PLASMA, Substantially Equivalent on 1982-02-23. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1982-01-12
Decision date: 1982-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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