The following data is part of a premarket notification filed by Orgentec with the FDA for Orgen Tec Anti-dsdna Elisa Assay.
| Device ID | K953671 |
| 510k Number | K953671 |
| Device Name: | ORGEN TEC ANTI-DSDNA ELISA ASSAY |
| Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Applicant | ORGENTEC P.O. BOX 451 Windham, NH 03087 |
| Contact | Richard Conley |
| Correspondent | Richard Conley ORGENTEC P.O. BOX 451 Windham, NH 03087 |
| Product Code | LRM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1995-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260157080683 | K953671 | 000 |
| 00840239035646 | K953671 | 000 |
| 00840239035653 | K953671 | 000 |
| 00840239035660 | K953671 | 000 |
| 04048474034387 | K953671 | 000 |
| 04048474035643 | K953671 | 000 |
| 04048474035650 | K953671 | 000 |
| 04048474035667 | K953671 | 000 |
| 00404847434385 | K953671 | 000 |
| 00404847435641 | K953671 | 000 |
| 00404847435658 | K953671 | 000 |
| 00404847435665 | K953671 | 000 |
| 00840239034380 | K953671 | 000 |