The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Ii Ana Screen Elisa.
| Device ID | K983655 |
| 510k Number | K983655 |
| Device Name: | AUTOSTAT II ANA SCREEN ELISA |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| 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 | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-19 |
| Decision Date | 1999-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879020212 | K983655 | 000 |