Precision Biologicals, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML), CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML), CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Precision Biologicals, Inc. Hematology ✕
18 devices
Cleared
Jan 13, 1999
CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15...
Hematology
287d
Cleared
Jan 13, 1999
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15...
Hematology
287d
Cleared
Jan 13, 1999
CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
Hematology
212d
Cleared
Aug 29, 1997
CRYO CHECK INR VALIDATION SET
Hematology
149d
Cleared
Aug 19, 1997
CRYO CHECK APC RESISTANT PLASMA
Hematology
139d
Cleared
Jul 22, 1997
CRYO CHECK FACTOR V DEFICIENT PLASMA
Hematology
111d
Cleared
Jul 18, 1997
CRYO CHECK FACTOR IX DEFICIENT PLASMA
Hematology
107d
Cleared
Jul 18, 1997
CRYO CHECK FACTOR X DEFICIENT PLASMA
Hematology
107d
Cleared
Jul 17, 1997
CRYO CHECK FACTOR VII DEFICIENT PLASMA
Hematology
106d
Cleared
Jul 17, 1997
CRYO CHECK FACTOR VIII DEFICIENT PLASMA
Hematology
106d
Cleared
Jan 03, 1996
CRYO CHECK LOW FIBRINOGEN CONTROL
Hematology
258d
Cleared
Nov 06, 1995
CRYO CHECK LUPUS PLASMA
Hematology
151d