The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for D-chem Total T4 Test Kit For Thyroxine Quantita..
| Device ID | K896329 |
| 510k Number | K896329 |
| Device Name: | D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | PHOTEC DIAGNOSTICS, INC. 200 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Barry Mcdonald |
| Correspondent | Barry Mcdonald PHOTEC DIAGNOSTICS, INC. 200 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-02 |
| Decision Date | 1989-12-12 |