LKB-WALLACE 1251 LUMINOMETER

Colorimeter, Photometer, Spectrophotometer For Clinical Use

LKB INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Lkb-wallace 1251 Luminometer.

Pre-market Notification Details

Device IDK820217
510k NumberK820217
Device Name:LKB-WALLACE 1251 LUMINOMETER
ClassificationColorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJQ  
CFR Regulation Number862.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-01-26
Decision Date1982-02-12

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