The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Ii Anti-gpc Elisa, Hy.tec Anti-gpc Elisa.
| Device ID | K991942 |
| 510k Number | K991942 |
| Device Name: | AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA |
| Classification | Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control |
| 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 | MLE |
| CFR Regulation Number | 866.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-09 |
| Decision Date | 1999-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879020106 | K991942 | 000 |