The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for The Theratest El-ana Profiles.
| Device ID | K914454 |
| 510k Number | K914454 |
| Device Name: | THE THERATEST EL-ANA PROFILES |
| Classification | Antinuclear Antibody, Antigen, Control |
| 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 | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-07 |
| Decision Date | 1992-05-22 |