LACTATE DEHYDROGENASE COLORIMETRIC SUB.

Electrophoretic, Lactate Dehydrogenase Isoenzymes

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Lactate Dehydrogenase Colorimetric Sub..

Pre-market Notification Details

Device IDK780080
510k NumberK780080
Device Name:LACTATE DEHYDROGENASE COLORIMETRIC SUB.
ClassificationElectrophoretic, Lactate Dehydrogenase Isoenzymes
Applicant CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCFE  
CFR Regulation Number862.1445 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-01-16
Decision Date1978-02-07

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