Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Precision Biologicals with 20 510(k) clearances. The most recent is a 510(k) clearance dated Jan 13, 1999: CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML).
| Jan 13, 1999 | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)K981173 · GJT | 510(k) clearances |
| Jan 13, 1999 | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)K981174 · GJT | 510(k) clearances |
| Jan 13, 1999 | CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10K982062 · GGW | 510(k) clearances |
| Aug 29, 1997 | CRYO CHECK INR VALIDATION SETK971219 · GGN | 510(k) clearances |
| Aug 19, 1997 | CRYO CHECK APC RESISTANT PLASMAK971222 · GGN | 510(k) clearances |
| Jul 22, 1997 | CRYO CHECK FACTOR V DEFICIENT PLASMAK971223 · GJT | 510(k) clearances |
| Jul 18, 1997 | CRYO CHECK FACTOR X DEFICIENT PLASMAK971227 · GJT | 510(k) clearances |
| Jul 18, 1997 | CRYO CHECK FACTOR IX DEFICIENT PLASMAK971226 · GJT | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
