FACTOR DEFICIENT PLASMA— 510(k) K961929

Name: FDA 510(k) clearance K961929
Creator: U.S. Food and Drug Administration
Published: 1996-10-10

Substantially Equivalent

Universal Reagents, Inc.

FDA 510(k) clearance K961929 for FACTOR DEFICIENT PLASMA, Substantially Equivalent on 1996-10-10. Applicant: Universal Reagents, Inc.. Device class: 2.

Clearance details

Applicant: Universal Reagents, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1996-05-17
Decision date: 1996-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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