The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Anti-cardiolipin Antibody Test System.
| Device ID | K911661 |
| 510k Number | K911661 |
| Device Name: | ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento, CA 95827 |
| Contact | Eric S Hoy |
| Correspondent | Eric S Hoy IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento, CA 95827 |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-12 |
| Decision Date | 1991-12-09 |