Precision Biologicals, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 20
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K981174 | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) | January 13, 1999 |
| K982062 | CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 | January 13, 1999 |
| K981173 | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) | January 13, 1999 |
| K971219 | CRYO CHECK INR VALIDATION SET | August 29, 1997 |
| K971222 | CRYO CHECK APC RESISTANT PLASMA | August 19, 1997 |
| K971223 | CRYO CHECK FACTOR V DEFICIENT PLASMA | July 22, 1997 |
| K971226 | CRYO CHECK FACTOR IX DEFICIENT PLASMA | July 18, 1997 |
| K971227 | CRYO CHECK FACTOR X DEFICIENT PLASMA | July 18, 1997 |
| K971224 | CRYO CHECK FACTOR VII DEFICIENT PLASMA | July 17, 1997 |
| K971225 | CRYO CHECK FACTOR VIII DEFICIENT PLASMA | July 17, 1997 |
| K951823 | CRYO CHECK LOW FIBRINOGEN CONTROL | January 3, 1996 |
| K952623 | CRYO CHECK LUPUS PLASMA | November 6, 1995 |
| K952622 | CRYO CHECK NORMAL HUMAN REFERENCE PLASMA | October 30, 1995 |
| K952624 | CRYO CHECK ABNORMAL REFERENCE CHECK I & II | October 30, 1995 |
| K922887 | CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM | February 25, 1993 |
| K885244 | SAF FECAL COLLECTION KIT | March 21, 1989 |
| K885245 | CARY-BLAIR TRANSPORT SYSTEM | March 21, 1989 |
| K884854 | COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL) | January 30, 1989 |
| K884856 | APTT REAGENT | January 30, 1989 |
| K884855 | THROMBOPLASTIN | January 30, 1989 |