Precision Biologic, Inc.
Precision Biologic, Inc. appears in FDA public data with 0 recalls, 17 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 25, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 17
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251440 | CRYOcheck Chromogenic Factor VIII | August 25, 2025 |
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | September 13, 2023 |
| K214002 | CRYOcheck Chromogenic Factor IX | December 23, 2022 |
| K193556 | Cryocheck Hex LA | October 23, 2020 |
| K193204 | Cryocheck Chromogenic Factor VIII | July 17, 2020 |
| K183440 | CRYOcheck FVIII Inhibitor Kit | March 12, 2019 |
| K060284 | CRYOCHECK CLOT APCR | May 10, 2006 |
| K043571 | CRYOCHECK CLOT S | March 18, 2005 |
| K040987 | CRYOCHECK CLOT C | June 18, 2004 |
| K032804 | CRYOCHECK WEAK LUPUS POSITIVE CONTROL | November 3, 2003 |
| K023991 | CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 | April 28, 2003 |
| K023990 | CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 | March 19, 2003 |
| K013708 | REFERENCE CHECK, CATALOG NUMBER-RCN-10 | December 10, 2001 |
| K990580 | CRYOCHECK LA SURE, MODEL SUR25-10 | July 28, 1999 |
| K990579 | CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) | July 23, 1999 |
| K990814 | CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 | June 7, 1999 |
| K990296 | CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) | March 18, 1999 |