The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for El-ana Profiles: Anti-chromatin.
| Device ID | K040291 |
| 510k Number | K040291 |
| Device Name: | EL-ANA PROFILES: ANTI-CHROMATIN |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | THERATEST LABORATORIES, INC. 1111 N. MAIN ST. Lombard, IL 60148 |
| Contact | Marius Teodorescu |
| Correspondent | Marius Teodorescu THERATEST LABORATORIES, INC. 1111 N. MAIN ST. Lombard, IL 60148 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-06 |
| Decision Date | 2004-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854473003187 | K040291 | 000 |