The following data is part of a premarket notification filed by Precision Biologic with the FDA for Cryocheck Chromogenic Factor Viii.
| Device ID | K193204 |
| 510k Number | K193204 |
| Device Name: | Cryocheck Chromogenic Factor VIII |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | Precision BioLogic 140 Eileen Stubbs Avenue Dartmouth, CA B3b 0a9 |
| Contact | Karen Black |
| Correspondent | Karen Black Precision BioLogic 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 | 2019-11-20 |
| Decision Date | 2020-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843876000558 | K193204 | 000 |