Precision Biologicals, Inc.
Dartmouth, CA
Precision Biologicals, Inc. appears in FDA device records in Dartmouth, CA. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Precision Biologicals, Inc. between 1989 and 1999. The busiest year on record is 1997, with 7. The most recent is 1999, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 5 |
| 1993 | 1 |
| 1995 | 3 |
| 1996 | 1 |
| 1997 | 7 |
| 1999 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K982062 | CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 | GGW | Substantially Equivalent | |
| K981174 | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) | GJT | Substantially Equivalent | |
| K981173 | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) | GJT | Substantially Equivalent | |
| K971219 | CRYO CHECK INR VALIDATION SET | GGN | Substantially Equivalent | |
| K971222 | CRYO CHECK APC RESISTANT PLASMA | GGN | Substantially Equivalent | |
| K971223 | CRYO CHECK FACTOR V DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K971227 | CRYO CHECK FACTOR X DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K971226 | CRYO CHECK FACTOR IX DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K971225 | CRYO CHECK FACTOR VIII DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K971224 | CRYO CHECK FACTOR VII DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K951823 | CRYO CHECK LOW FIBRINOGEN CONTROL | GGN | Substantially Equivalent | |
| K952623 | CRYO CHECK LUPUS PLASMA | GGC | Substantially Equivalent | |
| K952624 | CRYO CHECK ABNORMAL REFERENCE CHECK I & II | GGC | Substantially Equivalent | |
| K952622 | CRYO CHECK NORMAL HUMAN REFERENCE PLASMA | GGN | Substantially Equivalent | |
| K922887 | CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM | GGN | Substantially Equivalent | |
| K885245 | CARY-BLAIR TRANSPORT SYSTEM | JSM | Substantially Equivalent | |
| K885244 | SAF FECAL COLLECTION KIT | JSM | Substantially Equivalent | |
| K884856 | APTT REAGENT | GFO | Substantially Equivalent | |
| K884855 | THROMBOPLASTIN | GJS | Substantially Equivalent | |
| K884854 | COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL) | GGN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain