The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Delfia(tm) Triiodothyronine (t3) Kit.
| Device ID | K864452 |
| 510k Number | K864452 |
| Device Name: | DELFIA(TM) TRIIODOTHYRONINE (T3) KIT |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | LKB INSTRUMENTS, INC. 9319 GAITHER RD. Gaithersburg, MD 20877 |
| Contact | Ed Zior |
| Correspondent | Ed Zior LKB INSTRUMENTS, INC. 9319 GAITHER RD. Gaithersburg, MD 20877 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-12 |
| Decision Date | 1987-02-02 |