The following data is part of a premarket notification filed by Precision Biologic Inc. with the FDA for Cryocheck Fviii Inhibitor Kit.
| Device ID | K183440 |
| 510k Number | K183440 |
| Device Name: | CRYOcheck FVIII Inhibitor Kit |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | Precision BioLogic Inc. 140 Eileen Stubbs Avenue Dartmouth, CA B3b 0a9 |
| Contact | Karen M. Black |
| Correspondent | Karen M. Black Precision BioLogic Inc. 140 Eileen Stubbs Avenue Dartmouth, CA B3b 0a9 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-12 |
| Decision Date | 2019-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843876000503 | K183440 | 000 |