The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Orgentec Anti-tpo Elisa.
| Device ID | K952129 |
| 510k Number | K952129 |
| Device Name: | ORGENTEC ANTI-TPO ELISA |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | AMERICAN LABORATORY PRODUCTS CO., LTD. 7 COLCHESTER RD. Windham, NH 03087 |
| Contact | Richard E Conley |
| Correspondent | Richard E Conley AMERICAN LABORATORY PRODUCTS CO., LTD. 7 COLCHESTER RD. 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 | 1995-05-08 |
| Decision Date | 1995-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260157080027 | K952129 | 000 |
| 00404847435610 | K952129 | 000 |
| 04048474035612 | K952129 | 000 |
| 00840239035615 | K952129 | 000 |