The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Delfia(tm) Ferritin Kit.
| Device ID | K872955 |
| 510k Number | K872955 |
| Device Name: | DELFIA(TM) FERRITIN KIT |
| Classification | Radioimmunoassay (two-site Solid Phase), Ferritin |
| 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 | JMG |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-29 |
| Decision Date | 1987-08-21 |