COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA— 510(k) K853462

Name: FDA 510(k) clearance K853462
Creator: U.S. Food and Drug Administration
Published: 1985-08-29

Substantially Equivalent

American Dade

FDA 510(k) clearance K853462 for COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA, Substantially Equivalent on 1985-08-29. 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: 1985-08-19
Decision date: 1985-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.