The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for Theratest El-ana Profiles Test System.
| Device ID | K950716 |
| 510k Number | K950716 |
| Device Name: | THERATEST EL-ANA PROFILES TEST SYSTEM |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago, IL 60612 -3501 |
| Contact | Marius Teodorescu |
| Correspondent | Marius Teodorescu THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago, IL 60612 -3501 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-31 |
| Decision Date | 1995-09-26 |