The following data is part of a premarket notification filed by Precision Biologic with the FDA for Chromocheck Antithrombin 25; Chromocheck Antithrombin 50.
| Device ID | K023991 |
| 510k Number | K023991 |
| Device Name: | CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 |
| Classification | Antithrombin Iii Quantitation |
| Applicant | PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7 |
| Contact | Stephen L Duff |
| Correspondent | Stephen L Duff PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-03 |
| Decision Date | 2003-04-28 |
| Summary: | summary |