FACTOR DEFICIENT PLASMAS - FACTOR IX (9)— 510(k) K972288

Substantially Equivalent

Universal Reagents, Inc.

FDA 510(k) clearance K972288 for FACTOR DEFICIENT PLASMAS - FACTOR IX (9), Substantially Equivalent on 1997-07-14. Applicant: Universal Reagents, Inc..

Clearance details

Applicant: Universal Reagents, Inc.
Product code: Code GGP
Advisory panel: Hematology
Date received: 1997-06-19
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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