The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for El-anca: Anti-mpo, Anti-pr3, Anti-mpo And Anti-pr3.
| Device ID | K061376 |
| 510k Number | K061376 |
| Device Name: | EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | THERATEST LABORATORIES, INC. 1111 N. MAIN ST. Lombard, IL 60148 |
| Contact | Marius Teodorescu, Md, Ph.d. |
| Correspondent | Marius Teodorescu, Md, Ph.d. THERATEST LABORATORIES, INC. 1111 N. MAIN ST. Lombard, IL 60148 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-17 |
| Decision Date | 2006-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854473003248 | K061376 | 000 |
| 00854473003231 | K061376 | 000 |