The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Counter, Rack Gamma (#1270).
Device ID | K760470 |
510k Number | K760470 |
Device Name: | COUNTER, RACK GAMMA (#1270) |
Classification | Counter (beta, Gamma) For Clinical Use |
Applicant | LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJJ |
CFR Regulation Number | 862.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-19 |
Decision Date | 1976-11-01 |