Cleared Traditional

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

K981173 · Precision Biologicals, Inc. · Hematology

Jan 1999

Decision

287d

Days

Class 2

Risk

K981173 is an FDA 510(k) clearance for the CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML). This device is classified as 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 FDA review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number	K981173 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