CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)— 510(k) K981173

Name: FDA 510(k) clearance K981173
Creator: U.S. Food and Drug Administration
Published: 1999-01-13

Substantially Equivalent

Precision Biologicals, Inc.

FDA 510(k) clearance K981173 for CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML), Substantially Equivalent on 1999-01-13. Applicant: Precision Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: Precision Biologicals, Inc.
Product code: Code GJT
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1998-04-01
Decision date: 1999-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dartmouth, Nova Scotia, CA

Download summary PDF View on FDA.gov ↗

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