The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Ii Ena-4 Profile Elisa.
| Device ID | K003057 |
| 510k Number | K003057 |
| Device Name: | AUTOSTAT II ENA-4 PROFILE ELISA |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | COGENT DIAGNOTICS LTD. PENTLANDS SCIENCE PARK BUSH LOAN, PENICUIK Midlothian, Scotland, GB Eh26 Opl |
| Contact | Danielle Knight |
| Correspondent | Danielle Knight COGENT DIAGNOTICS LTD. PENTLANDS SCIENCE PARK BUSH LOAN, PENICUIK Midlothian, Scotland, GB Eh26 Opl |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-02 |
| Decision Date | 2000-10-13 |