UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA— 510(k) K964459

Name: FDA 510(k) clearance K964459
Creator: U.S. Food and Drug Administration
Published: 1996-12-18

Substantially Equivalent

Universal Reagents, Inc.

FDA 510(k) clearance K964459 for UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA, Substantially Equivalent on 1996-12-18. 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: 1996-11-07
Decision date: 1996-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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