The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostattmii Anti-dsdna.
| Device ID | K952567 |
| 510k Number | K952567 |
| Device Name: | AUTOSTATTMII ANTI-DSDNA |
| Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Applicant | COGENT DIAGNOTICS LTD. KINGS BUILDINGS, WEST MAINS RD Edinburgh, GB Eh9 3jf |
| Contact | Jim Weston |
| Correspondent | Jim Weston COGENT DIAGNOTICS LTD. KINGS BUILDINGS, WEST MAINS RD Edinburgh, GB Eh9 3jf |
| Product Code | LRM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-05 |
| Decision Date | 1997-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879020014 | K952567 | 000 |