The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Ii Anti-cardiolipin Screen Elisa.
| Device ID | K993085 |
| 510k Number | K993085 |
| Device Name: | AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | COGENT DIAGNOTICS LTD. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Contact | Randy Wilson |
| Correspondent | Randy Wilson COGENT DIAGNOTICS LTD. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-15 |
| Decision Date | 2000-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879020182 | K993085 | 000 |