The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for El-ana Profiles: El-ena/5.
| Device ID | K982622 |
| 510k Number | K982622 |
| Device Name: | EL-ANA PROFILES: EL-ENA/5 |
| Classification | Extractable Antinuclear Antibody, Antigen And 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 | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-18 |
| Decision Date | 1998-08-13 |