Medical Device Manufacturer · CA , Dartmouth

Precision Biologicals, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1989

Total

Cleared

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.

Precision Biologicals, Inc. is one of 208 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Precision Biologicals, Inc.

20 devices

1-20 of 20

Cleared Jan 13, 1999

CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15...

K981173 · GJT

Hematology · 287d

Cleared Jan 13, 1999

CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15...

K981174 · GJT

Hematology · 287d

Cleared Jan 13, 1999

CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10

K982062 · GGW

Hematology · 212d

Cleared Aug 29, 1997

CRYO CHECK INR VALIDATION SET

K971219 · GGN

Hematology · 149d

Cleared Aug 19, 1997

CRYO CHECK APC RESISTANT PLASMA

K971222 · GGN

Hematology · 139d

Cleared Jul 22, 1997

CRYO CHECK FACTOR V DEFICIENT PLASMA

K971223 · GJT

Hematology · 111d

Cleared Jul 18, 1997

CRYO CHECK FACTOR IX DEFICIENT PLASMA

K971226 · GJT

Hematology · 107d

Cleared Jul 18, 1997

CRYO CHECK FACTOR X DEFICIENT PLASMA

K971227 · GJT

Hematology · 107d

Cleared Jul 17, 1997

CRYO CHECK FACTOR VII DEFICIENT PLASMA

K971224 · GJT

Hematology · 106d

Cleared Jul 17, 1997

CRYO CHECK FACTOR VIII DEFICIENT PLASMA

K971225 · GJT

Hematology · 106d

Cleared Jan 03, 1996

CRYO CHECK LOW FIBRINOGEN CONTROL

K951823 · GGN

Hematology · 258d

Cleared Nov 06, 1995

CRYO CHECK LUPUS PLASMA

K952623 · GGC

Hematology · 151d

Cleared Oct 30, 1995

CRYO CHECK NORMAL HUMAN REFERENCE PLASMA

K952622 · GGN

Hematology · 144d

Cleared Oct 30, 1995

CRYO CHECK ABNORMAL REFERENCE CHECK I & II

K952624 · GGC

Hematology · 144d

Cleared Feb 25, 1993

CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM

K922887 · GGN

Hematology · 254d

Cleared Mar 21, 1989

SAF FECAL COLLECTION KIT

K885244 · JSM

Microbiology · 89d

Cleared Mar 21, 1989

CARY-BLAIR TRANSPORT SYSTEM

K885245 · JSM

Microbiology · 89d

Cleared Jan 30, 1989

COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)

Precision Biologicals, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Precision Biologicals, Inc.

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