The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Reactifs, Ibf Ultrogels Aca & Ultrogels A.
Device ID | K844164 |
510k Number | K844164 |
Device Name: | REACTIFS, IBF ULTROGELS ACA & ULTROGELS A |
Classification | Columns, Glc |
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 | DII |
CFR Regulation Number | 862.2250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-25 |
Decision Date | 1984-12-10 |