Cleared Traditional

CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)

K981174 · Precision Biologicals, Inc. · Hematology
Jan 1999
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K981174 is an FDA 510(k) clearance for the CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML), a Plasma, Coagulation Factor Deficient (Class II — Special Controls, product code GJT), submitted by Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA). The FDA issued a Cleared decision on January 13, 1999, 287 days after receiving the submission on April 1, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K981174 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1998
Decision Date January 13, 1999
Days to Decision 287 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJT — Plasma, Coagulation Factor Deficient
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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