The following data is part of a premarket notification filed by Cardiovascular Diagnostic Services with the FDA for Coag-i Analyzer, Alpha Model.
| Device ID | K882444 |
| 510k Number | K882444 |
| Device Name: | COAG-I ANALYZER, ALPHA MODEL |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| 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 | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-14 |
| Decision Date | 1988-08-25 |