The following data is part of a premarket notification filed by Orgentec Diagnostika Gmbh with the FDA for Anti-mutated Citrullinated Vimentin Eia.
| Device ID | K092399 |
| 510k Number | K092399 |
| Device Name: | ANTI-MUTATED CITRULLINATED VIMENTIN EIA |
| Classification | Anti-mutated Citrullinated Vimentin Igg |
| Applicant | ORGENTEC DIAGNOSTIKA GMBH 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus ORGENTEC DIAGNOSTIKA GMBH 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Product Code | OQZ |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-06 |
| Decision Date | 2010-07-01 |
| Summary: | summary |