The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Ii Anti-pr 3 (c-anca)elisa, Hy*tec Anti-pr 3 (c-anca)elisa.
| Device ID | K990796 |
| 510k Number | K990796 |
| Device Name: | AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | COGENT DIAGNOTICS LTD. PENTLANDS SCIENCE PARK BUSH LOAN, PENICUIK Midlothian, Scotland, GB Eh26 Opl |
| Contact | Danielle M Knight |
| Correspondent | Danielle M Knight COGENT DIAGNOTICS LTD. PENTLANDS SCIENCE PARK BUSH LOAN, PENICUIK Midlothian, Scotland, GB Eh26 Opl |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-10 |
| Decision Date | 1999-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879020113 | K990796 | 000 |