The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Lkb 2230 Rotary One.
Device ID | K843505 |
510k Number | K843505 |
Device Name: | LKB 2230 ROTARY ONE |
Classification | Microtome, Rotary |
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 | IDO |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-06 |
Decision Date | 1984-11-30 |