Medical Device Manufacturer · CA , Dartmouth

Precision Biologicals, Inc.

20 submissions · 20 cleared · Since 1989
20
Total
20
Cleared
0
Denied

Precision Biologicals, Inc. has 20 FDA 510(k) cleared hematology devices. Based in Dartmouth, CA.

Historical record: 20 cleared submissions from 1989 to 1999.

Browse the complete list of FDA 510(k) cleared hematology devices from this manufacturer. Filter by specialty or product code using the sidebar.

20 devices
1–12 of 20
CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
K981173 · GJT Plasma, Coagulation Factor Deficient · Hematology
Jan 1999 287d
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
K981174 · GJT Plasma, Coagulation Factor Deficient · Hematology
Jan 1999 287d
CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
K982062 · GGW Test, Time, Partial Thromboplastin · Hematology
Jan 1999 212d
CRYO CHECK INR VALIDATION SET
K971219 · GGN Plasma, Coagulation Control · Hematology
Aug 1997 149d
CRYO CHECK APC RESISTANT PLASMA
K971222 · GGN Plasma, Coagulation Control · Hematology
Aug 1997 139d
CRYO CHECK FACTOR V DEFICIENT PLASMA
K971223 · GJT Plasma, Coagulation Factor Deficient · Hematology
Jul 1997 111d
CRYO CHECK FACTOR IX DEFICIENT PLASMA
K971226 · GJT Plasma, Coagulation Factor Deficient · Hematology
Jul 1997 107d
CRYO CHECK FACTOR X DEFICIENT PLASMA
K971227 · GJT Plasma, Coagulation Factor Deficient · Hematology
Jul 1997 107d
CRYO CHECK FACTOR VII DEFICIENT PLASMA
K971224 · GJT Plasma, Coagulation Factor Deficient · Hematology
Jul 1997 106d
CRYO CHECK FACTOR VIII DEFICIENT PLASMA
K971225 · GJT Plasma, Coagulation Factor Deficient · Hematology
Jul 1997 106d
CRYO CHECK LOW FIBRINOGEN CONTROL
K951823 · GGN Plasma, Coagulation Control · Hematology
Jan 1996 258d
CRYO CHECK LUPUS PLASMA
K952623 · GGC Control, Plasma, Abnormal · Hematology
Nov 1995 151d
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