The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Lbk 1244 Delfia Hcg Kit.
| Device ID | K852760 |
| 510k Number | K852760 |
| Device Name: | LBK 1244 DELFIA HCG KIT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-28 |
| Decision Date | 1985-12-05 |