Cleared Traditional

CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)

K990296 · Precision Biologic · Hematology

Mar 1999

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K990296 is an FDA 510(k) clearance for the CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML), a Plasma, Coagulation Factor Deficient (Class II — Special Controls, product code GJT), submitted by Precision Biologic (Dartmouth, N.S., CA). The FDA issued a Cleared decision on March 18, 1999, 49 days after receiving the submission on January 28, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number	K990296 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 1999
Decision Date	March 18, 1999
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement