FDA 510(k) Applications Submitted by Precision BioLogic

FDA 510(k) Number Submission Date Device Name Applicant
K193204 11/20/2019 Cryocheck Chromogenic Factor VIII Precision BioLogic
K193556 12/23/2019 Cryocheck Hex LA Precision BioLogic
K990296 01/28/1999 CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) PRECISION BIOLOGIC
K990579 02/23/1999 CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) PRECISION BIOLOGIC
K990580 02/23/1999 CRYOCHECK LA SURE, MODEL SUR25-10 PRECISION BIOLOGIC
K990814 03/11/1999 CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 PRECISION BIOLOGIC
K032804 09/09/2003 CRYOCHECK WEAK LUPUS POSITIVE CONTROL PRECISION BIOLOGIC
K013708 11/08/2001 REFERENCE CHECK, CATALOG NUMBER-RCN-10 PRECISION BIOLOGIC
K023990 12/03/2002 CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 PRECISION BIOLOGIC
K023991 12/03/2002 CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 PRECISION BIOLOGIC


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