Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Precision Biologic with 17 510(k) clearances. The most recent is a 510(k) clearance dated Aug 25, 2025: CRYOcheck Chromogenic Factor VIII.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 25, 2025 | CRYOcheck Chromogenic Factor VIIIK251440 · GGP | 510(k) clearances |
| Sep 13, 2023 | CRYOcheck Factor VIII Deficient Plasma with VWFK222831 · GJT | 510(k) clearances |
| Dec 23, 2022 | CRYOcheck Chromogenic Factor IXK214002 · GGP | 510(k) clearances |
| Oct 23, 2020 | Cryocheck Hex LAK193556 · GFO | 510(k) clearances |
| Jul 17, 2020 | Cryocheck Chromogenic Factor VIIIK193204 · GGP | 510(k) clearances |
| Mar 12, 2019 | CRYOcheck FVIII Inhibitor KitK183440 · GGP | 510(k) clearances |
| May 10, 2006 | CRYOCHECK CLOT APCRK060284 · GGW | 510(k) clearances |
| Mar 18, 2005 | CRYOCHECK CLOT SK043571 · GGP | 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
