CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL— 510(k) K802142

Name: FDA 510(k) clearance K802142
Creator: U.S. Food and Drug Administration
Published: 1980-10-10

Substantially Equivalent

American Dade

FDA 510(k) clearance K802142 for CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL, Substantially Equivalent on 1980-10-10. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1980-09-05
Decision date: 1980-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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