The following data is part of a premarket notification filed by Micro Detect, Inc. with the FDA for Mdi Scl-70 Test.
| Device ID | K000934 |
| 510k Number | K000934 |
| Device Name: | MDI SCL-70 TEST |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | MICRO DETECT, INC. 2852 WALNUT AVE., SUITE H-1 Tustin, CA 92780 -7033 |
| Contact | Mehdi Alem |
| Correspondent | Mehdi Alem MICRO DETECT, INC. 2852 WALNUT AVE., SUITE H-1 Tustin, CA 92780 -7033 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-23 |
| Decision Date | 2000-04-07 |