UNIPAK 100 ANALYZER, 65156 & CHEMISTR

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

EMD CHEMICALS INC.

The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Unipak 100 Analyzer, 65156 & Chemistr.

Pre-market Notification Details

Device IDK840883
510k NumberK840883
Device Name:UNIPAK 100 ANALYZER, 65156 & CHEMISTR
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant EMD CHEMICALS INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-27
Decision Date1984-05-16

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