The following data is part of a premarket notification filed by Micro Detect, Inc. with the FDA for Mdi Ss-b Test Enzyme Immunoassay For The Detection Of Autoantibodies To Ss-b In Human Serum.
| Device ID | K993971 |
| 510k Number | K993971 |
| Device Name: | MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | MICRO DETECT, INC. 2852 WALNUT AVE., SUITE H-1 Tustin, CA 92780 |
| Contact | Mehdi Alem |
| Correspondent | Mehdi Alem MICRO DETECT, INC. 2852 WALNUT AVE., SUITE H-1 Tustin, CA 92780 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-23 |
| Decision Date | 2000-01-11 |
| Summary: | summary |