The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Delfia (tm) Hfsh Kit.
| Device ID | K862043 |
| 510k Number | K862043 |
| Device Name: | DELFIA (TM) HFSH KIT |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| 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 | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-28 |
| Decision Date | 1986-06-24 |