STAGO FACTOR V-DEFICIENT PLASMA— 510(k) K934605

Name: FDA 510(k) clearance K934605
Creator: U.S. Food and Drug Administration
Published: 1994-03-01

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K934605 for STAGO FACTOR V-DEFICIENT PLASMA, Substantially Equivalent on 1994-03-01. Applicant: American Bioproducts Co.. Device class: 2.

Clearance details

Applicant: American Bioproducts Co.
Product code: Code GJT
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1993-09-27
Decision date: 1994-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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