The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Orgen Tec Anti-dsdna Pin Immuno Assay.
| Device ID | K952055 |
| 510k Number | K952055 |
| Device Name: | ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY |
| Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Applicant | AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham, NH 03087 |
| Contact | Richard Conley |
| Correspondent | Richard Conley AMERICAN LABORATORY PRODUCTS CO., LTD. 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 | 1995-05-02 |
| Decision Date | 1995-07-18 |