The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for Theratest El-anti-ccp/2.
| Device ID | K090753 |
| 510k Number | K090753 |
| Device Name: | THERATEST EL-ANTI-CCP/2 |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| 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 | NHX |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-20 |
| Decision Date | 2010-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854473003019 | K090753 | 000 |