The following data is part of a premarket notification filed by Precision Biologic Inc. with the FDA for Cryocheck Clot Apcr.
| Device ID | K060284 |
| 510k Number | K060284 |
| Device Name: | CRYOCHECK CLOT APCR |
| Classification | Test, Time, Partial Thromboplastin |
| 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 | GGW |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-03 |
| Decision Date | 2006-05-10 |
| Summary: | summary |