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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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