The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Orgentec Anti-tg/anti-tpo Pia (pin Immuno Assay).
| Device ID | K950088 |
| 510k Number | K950088 |
| Device Name: | ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham, NH 03087 |
| Contact | Richard E Conley |
| Correspondent | Richard E Conley AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham, NH 03087 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-10 |
| Decision Date | 1995-04-21 |