The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for D-chem(tm) T-uptake Test Kit For T-uptake Determin.
Device ID | K892224 |
510k Number | K892224 |
Device Name: | D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN |
Classification | Radioassay, Triiodothyronine Uptake |
Applicant | PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls, NJ 07424 |
Contact | Barry Mcdonald |
Correspondent | Barry Mcdonald PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls, NJ 07424 |
Product Code | KHQ |
CFR Regulation Number | 862.1715 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-03 |
Decision Date | 1989-06-16 |