Precision Biologic

Medical device manufacturer in Dartmouth, CA.

17510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K251440CRYOcheck Chromogenic Factor VIIIGGP · Traditional 08/25/2025SE
K222831CRYOcheck Factor VIII Deficient Plasma with VWFGJT · Traditional 09/13/2023SE
K214002CRYOcheck Chromogenic Factor IXGGP · Traditional 12/23/2022SE
K193556Cryocheck Hex LAGFO · Traditional 10/23/2020SE
K193204Cryocheck Chromogenic Factor VIIIGGP · Traditional 07/17/2020SE
K183440CRYOcheck FVIII Inhibitor KitGGP · Traditional 03/12/2019SE
K060284Cryocheck Clot ApcrGGW · Traditional 05/10/2006SE
K043571Cryocheck Clot SGGP · Traditional 03/18/2005SE
K040987Cryocheck Clot CGGP · Traditional 06/18/2004SE
K032804Cryocheck Weak Lupus Positive ControlGGC · Traditional 11/03/2003SE
K023991Chromocheck Antithrombin 25; Chromocheck Antithrombin 50JBQ · Traditional 04/28/2003SE
K023990Chromocheck Protein C 25; Chromocheck Protein C 50GGP · Traditional 03/19/2003SE
K013708Reference Check, Catalog NUMBER-RCN-10GIZ · Traditional 12/10/2001SE
K990580Cryocheck la Sure, Model SUR25-10GIR · Traditional 07/28/1999SE
K990579Cryocheck la Check, Models CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)GIR · Traditional 07/23/1999SE
K990814Cryo Check Factor 2 Deficient Plasma, Models FDPO2-10, FDP02-15GJT · Traditional 06/07/1999SE
K990296Cryocheck Prekallikrein Deficient Plalsma, Model FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25…GJT · Traditional 03/18/1999SE