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 |