The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for 1208 Betacord And 1208 Betcord M.
| Device ID | K852434 |
| 510k Number | K852434 |
| Device Name: | 1208 BETACORD AND 1208 BETCORD M |
| Classification | Counter (beta, Gamma) For Clinical 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 | JJJ |
| CFR Regulation Number | 862.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-10 |
| Decision Date | 1985-08-02 |