The following data is part of a premarket notification filed by Precision Biologic Inc. with the FDA for Cryocheck Clot S.
| Device ID | K043571 |
| 510k Number | K043571 |
| Device Name: | CRYOCHECK CLOT S |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | PRECISION BIOLOGIC INC. 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7 |
| Contact | Stephen L Duff |
| Correspondent | Stephen L Duff PRECISION BIOLOGIC INC. 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-27 |
| Decision Date | 2005-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843876000428 | K043571 | 000 |
| 00843876000411 | K043571 | 000 |