The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Sm-rnp Autoantibody Test System.
| Device ID | K860428 |
| 510k Number | K860428 |
| Device Name: | SM-RNP AUTOANTIBODY TEST SYSTEM |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento, CA 95827 |
| Contact | Don W Valencia |
| Correspondent | Don W Valencia IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento, CA 95827 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-04 |
| Decision Date | 1986-05-15 |