The following data is part of a premarket notification filed by Orgentec with the FDA for Orgentec Anti-scl 70 Pin Immuno Assay.
| Device ID | K954814 |
| 510k Number | K954814 |
| Device Name: | ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| 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 | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-19 |
| Decision Date | 1996-04-18 |