The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Delfia (tm) Hcg Kit.
| Device ID | K862044 |
| 510k Number | K862044 |
| Device Name: | DELFIA (TM) HCG KIT |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| 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 | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-28 |
| Decision Date | 1986-07-11 |