The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Roche Elecsys Anti-ccp Immunoassay, Roche Elecsys Precicontrol Anti-ccp.
| Device ID | K081338 |
| 510k Number | K081338 |
| Device Name: | ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Applicant | Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Stephanie Greeman |
| Correspondent | Stephanie Greeman Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | NHX |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-13 |
| Decision Date | 2008-09-11 |
| Summary: | summary |