The following data is part of a premarket notification filed by Orgentec Diagnostika Gmbh with the FDA for Orgentec Rheumatoid Factor Eia.
| Device ID | K100499 |
| 510k Number | K100499 |
| Device Name: | ORGENTEC RHEUMATOID FACTOR EIA |
| Classification | System, Test, Rheumatoid Factor |
| 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 | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-22 |
| Decision Date | 2010-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00404847435863 | K100499 | 000 |
| 00840239035837 | K100499 | 000 |
| 00840239035844 | K100499 | 000 |
| 00840239035851 | K100499 | 000 |
| 00840239035868 | K100499 | 000 |
| 04048474035841 | K100499 | 000 |
| 04048474035858 | K100499 | 000 |
| 04048474035865 | K100499 | 000 |
| 00404847435849 | K100499 | 000 |
| 00404847435856 | K100499 | 000 |
| 04048474035834 | K100499 | 000 |