ISO-SEP SYSTEM

Chromatographic Separation, Lactate Dehydrogenase Isoenzymes

BERWICK MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Berwick Medical Products, Inc. with the FDA for Iso-sep System.

Pre-market Notification Details

Device IDK842018
510k NumberK842018
Device Name:ISO-SEP SYSTEM
ClassificationChromatographic Separation, Lactate Dehydrogenase Isoenzymes
Applicant BERWICK MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCEX  
CFR Regulation Number862.1445 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-18
Decision Date1984-09-28

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