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 |