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 |