The following data is part of a premarket notification filed by Cardiovascular Diagnostic Services with the FDA for Coag-1 Pt-nc Test Card.
| Device ID | K904325 |
| 510k Number | K904325 |
| Device Name: | COAG-1 PT-NC TEST CARD |
| Classification | Test, Time, Prothrombin |
| Applicant | CARDIOVASCULAR DIAGNOSTIC SERVICES P.O. BOX 14025 2810 MERIDIAN PKWY SUITE 106 Research Triangle Park, NC 27709 |
| Contact | Sharon C Dermott |
| Correspondent | Sharon C Dermott CARDIOVASCULAR DIAGNOSTIC SERVICES P.O. BOX 14025 2810 MERIDIAN PKWY SUITE 106 Research Triangle Park, NC 27709 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-20 |
| Decision Date | 1991-01-25 |