Data / Medical devices / Canada / Precision BioLogic Inc.
Precision BioLogic Inc.: FDA-registered device maker in Dartmouth Nova Scotia, Canada, 27 510(k) clearances
Precision BioLogic Inc. is registered with the FDA (registration 8043599) in Dartmouth Nova Scotia, Canada. It lists 8 device types. The FDA files 27 510(k) clearances under its listings, the newest dated August 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043599
- FEI number
- 3005917516
- Address
- 140 Eileen Stubbs Avenue, Dartmouth Nova Scotia, Canada, B3B 0A9
- Owner or operator
- Precision BioLogic (9002573)
- Roles
- Manufacturer
- First device listed
- December 4, 2007
- Registered through
- 2026
- Brand names listed
- CRYOCHECK APCR Positive Control, CRYOCHECK Abnormal 1 Control, CRYOCHECK Abnormal 1 Reference Control, CRYOCHECK Abnormal 2 Control, CRYOCHECK Abnormal 2 Reference Control, CRYOCHECK Clot C, CRYOCHECK FVIII Inhibitor Kit, CRYOCHECK Factor II Deficient Plasma and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activated Partial Thromboplastin | GFO | 2 | Manufacturer | accessdata.fda.gov |
| Control, Plasma, Abnormal | GGC | 2 | Manufacturer | accessdata.fda.gov |
| Plasma, Coagulation Control | GGN | 2 | Manufacturer | accessdata.fda.gov |
| Plasma, Coagulation Factor Deficient | GJT | 2 | Manufacturer | accessdata.fda.gov |
| Plasma, Control, Normal | GIZ | 2 | Manufacturer | accessdata.fda.gov |
| Reagent, Russel Viper Venom | GIR | 1 | Manufacturer | accessdata.fda.gov |
| Test, Qualitative And Quantitative Factor Deficiency | GGP | 2 | Manufacturer | accessdata.fda.gov |
| Test, Time, Partial Thromboplastin | GGW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 25, 2025 | K251440 | CRYOcheck Chromogenic Factor VIII | GGP | Substantially Equivalent | Precision Biologic, Inc. | accessdata.fda.gov |
| September 13, 2023 | K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | GJT | Substantially Equivalent | Precision Biologic, Inc. | accessdata.fda.gov |
| December 23, 2022 | K214002 | CRYOcheck Chromogenic Factor IX | GGP | Substantially Equivalent | Precision Biologic, Inc. | accessdata.fda.gov |
| October 23, 2020 | K193556 | Cryocheck Hex LA | GFO | Substantially Equivalent | Precision Biologic | accessdata.fda.gov |
| July 17, 2020 | K193204 | Cryocheck Chromogenic Factor VIII | GGP | Substantially Equivalent | Precision Biologic | accessdata.fda.gov |
| March 12, 2019 | K183440 | CRYOcheck FVIII Inhibitor Kit | GGP | Substantially Equivalent | Precision Biologic, Inc. | accessdata.fda.gov |
| June 18, 2004 | K040987 | CRYOCHECK CLOT C | GGP | Substantially Equivalent | Precision Biologic, Inc. | accessdata.fda.gov |
| November 3, 2003 | K032804 | CRYOCHECK WEAK LUPUS POSITIVE CONTROL | GGC | Substantially Equivalent | Precision Biologic | accessdata.fda.gov |
| December 10, 2001 | K013708 | REFERENCE CHECK, CATALOG NUMBER-RCN-10 | GIZ | Substantially Equivalent | Precision Biologic | accessdata.fda.gov |
| July 28, 1999 | K990580 | CRYOCHECK LA SURE, MODEL SUR25-10 | GIR | Substantially Equivalent | Precision Biologic | accessdata.fda.gov |
| July 23, 1999 | K990579 | CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) | GIR | Substantially Equivalent | Precision Biologic | accessdata.fda.gov |
| June 7, 1999 | K990814 | CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 | GJT | Substantially Equivalent | Precision Biologic | accessdata.fda.gov |
| March 18, 1999 | K990296 | CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) | GJT | Substantially Equivalent | Precision Biologic | accessdata.fda.gov |
| January 13, 1999 | K982062 | CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 | GGW | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
| January 13, 1999 | K981174 | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) | GJT | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
| January 13, 1999 | K981173 | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) | GJT | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
| August 19, 1997 | K971222 | CRYO CHECK APC RESISTANT PLASMA | GGN | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
| July 22, 1997 | K971223 | CRYO CHECK FACTOR V DEFICIENT PLASMA | GJT | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
| July 18, 1997 | K971227 | CRYO CHECK FACTOR X DEFICIENT PLASMA | GJT | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
| July 18, 1997 | K971226 | CRYO CHECK FACTOR IX DEFICIENT PLASMA | GJT | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
| July 17, 1997 | K971225 | CRYO CHECK FACTOR VIII DEFICIENT PLASMA | GJT | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
| July 17, 1997 | K971224 | CRYO CHECK FACTOR VII DEFICIENT PLASMA | GJT | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
| January 3, 1996 | K951823 | CRYO CHECK LOW FIBRINOGEN CONTROL | GGN | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
| November 6, 1995 | K952623 | CRYO CHECK LUPUS PLASMA | GGC | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
| October 30, 1995 | K952624 | CRYO CHECK ABNORMAL REFERENCE CHECK I & II | GGC | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
| October 30, 1995 | K952622 | CRYO CHECK NORMAL HUMAN REFERENCE PLASMA | GGN | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
| February 25, 1993 | K922887 | CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM | GGN | Substantially Equivalent | Precision Biologicals, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Time, Partial Thromboplastin
- All makers of Plasma, Coagulation Control
- All makers of Plasma, Control, Normal
- All makers of Plasma, Coagulation Factor Deficient
- All makers of Control, Plasma, Abnormal
- All makers of Test, Qualitative And Quantitative Factor Deficiency
Updated August 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.