The following data is part of a premarket notification filed by Precision Biologic with the FDA for Cryocheck La Check, Models Chk25-10 (25 X1.0 Ml), Chk80-10 (80 X 1.0 Ml).
| Device ID | K990579 |
| 510k Number | K990579 |
| Device Name: | CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) |
| Classification | Reagent, Russel Viper Venom |
| Applicant | PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7 |
| Contact | Sandy Morrison |
| Correspondent | Sandy Morrison PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7 |
| Product Code | GIR |
| CFR Regulation Number | 864.8950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-23 |
| Decision Date | 1999-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843876000473 | K990579 | 000 |
| 00843876000466 | K990579 | 000 |
| 00843876000459 | K990579 | 000 |
| 00843876000442 | K990579 | 000 |