The following data is part of a premarket notification filed by Euroimmun Us Llc with the FDA for Euroimmun Anti-ccp Elisa.
| Device ID | K070789 |
| 510k Number | K070789 |
| Device Name: | EUROIMMUN ANTI-CCP ELISA |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Applicant | EUROIMMUN US LLC 429 ROCKAWAY VALLEY RD. UNIT 1200 Boonton, NJ 07005 |
| Contact | Kathryn Kohl |
| Correspondent | Kathryn Kohl EUROIMMUN US LLC 429 ROCKAWAY VALLEY RD. UNIT 1200 Boonton, NJ 07005 |
| Product Code | NHX |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-22 |
| Decision Date | 2007-12-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016026853 | K070789 | 000 |