Company ยท CA
Precision Biologic
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2025. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 7 |
| GJT | Plasma, Coagulation Factor Deficient | 3 |
| GIR | Reagent, Russel Viper Venom | 2 |
| GFO | Activated Partial Thromboplastin | 1 |
| GGC | Control, Plasma, Abnormal | 1 |
| GGW | Test, Time, Partial Thromboplastin | 1 |
| GIZ | Plasma, Control, Normal | 1 |
| JBQ | Antithrombin Iii Quantitation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2025 | K251440 | CRYOcheck Chromogenic Factor VIII Precision Biologic, Inc., CA | GGP |
| Sep 13, 2023 | K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF Precision Biologic, Inc., CA | GJT |
| Dec 23, 2022 | K214002 | CRYOcheck Chromogenic Factor IX Precision Biologic, Inc., CA | GGP |
| Oct 23, 2020 | K193556 | Cryocheck Hex LA Precision Biologic, CA | GFO |
| Jul 17, 2020 | K193204 | Cryocheck Chromogenic Factor VIII Precision Biologic, CA | GGP |
| Mar 12, 2019 | K183440 | CRYOcheck FVIII Inhibitor Kit Precision Biologic, Inc., CA | GGP |
| May 10, 2006 | K060284 | CRYOCHECK CLOT APCR Precision Biologic, Inc., CA | GGW |
| Mar 18, 2005 | K043571 | CRYOCHECK CLOT S Precision Biologic, Inc., CA | GGP |
| Jun 18, 2004 | K040987 | CRYOCHECK CLOT C Precision Biologic, Inc., CA | GGP |
| Nov 3, 2003 | K032804 | CRYOCHECK WEAK LUPUS POSITIVE CONTROL Precision Biologic, CA | GGC |
| Apr 28, 2003 | K023991 | CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 Precision Biologic, CA | JBQ |
| Mar 19, 2003 | K023990 | CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 Precision Biologic, CA | GGP |
| Dec 10, 2001 | K013708 | REFERENCE CHECK, CATALOG NUMBER-RCN-10 Precision Biologic, CA | GIZ |
| Jul 28, 1999 | K990580 | CRYOCHECK LA SURE, MODEL SUR25-10 Precision Biologic, CA | GIR |
| Jul 23, 1999 | K990579 | CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) Precision Biologic, CA | GIR |
| Jun 7, 1999 | K990814 | CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 Precision Biologic, CA | GJT |
| Mar 18, 1999 | K990296 | CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) Precision Biologic, CA | GJT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||