NEW STACHROM ANTIPLASMIN— 510(k) K921449

Name: FDA 510(k) clearance K921449
Creator: U.S. Food and Drug Administration
Published: 1992-09-23

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K921449 for NEW STACHROM ANTIPLASMIN, Substantially Equivalent on 1992-09-23. Applicant: American Bioproducts Co.. Device class: 2.

Clearance details

Applicant: American Bioproducts Co.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1992-03-26
Decision date: 1992-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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