The following data is part of a premarket notification filed by Orgentec with the FDA for Orgentec Enascreen Elisa Assay.
| Device ID | K955134 |
| 510k Number | K955134 |
| Device Name: | ORGENTEC ENASCREEN ELISA ASSAY |
| Classification | Extractable Antinuclear Antibody, Antigen And 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 | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-09 |
| Decision Date | 1996-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260157080034 | K955134 | 000 |
| 00404847435719 | K955134 | 000 |
| 04048474035711 | K955134 | 000 |
| 00840239035714 | K955134 | 000 |
| 00840239039019 | K955134 | 000 |
| 04048474039016 | K955134 | 000 |