IMMOBILINE SYSTEM LKB 1819

Apparatus, Electrophoresis, For Clinical Use

LKB INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Immobiline System Lkb 1819.

Pre-market Notification Details

Device IDK830797
510k NumberK830797
Device Name:IMMOBILINE SYSTEM LKB 1819
ClassificationApparatus, Electrophoresis, For Clinical Use
Applicant LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJN  
CFR Regulation Number862.2485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-14
Decision Date1983-08-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.