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Precision Biologic

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K193556	Cryocheck Hex LA	GFO	2020-10-23	View
510(k)	K193204	Cryocheck Chromogenic Factor VIII	GGP	2020-07-17	View
510(k)	K032804	CRYOCHECK WEAK LUPUS POSITIVE CONTROL	GGC	2003-11-03	View
510(k)	K023991	CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50	JBQ	2003-04-28	View
510(k)	K023990	CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50	GGP	2003-03-19	View
510(k)	K013708	REFERENCE CHECK, CATALOG NUMBER-RCN-10	GIZ	2001-12-10	View
510(k)	K990580	CRYOCHECK LA SURE, MODEL SUR25-10	GIR	1999-07-28	View
510(k)	K990579	CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)	GIR	1999-07-23	View
510(k)	K990814	CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15	GJT	1999-06-07	View
510(k)	K990296	CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)	GJT	1999-03-18	View

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