HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207

Electrophoretic Separation, Lipoproteins

MORAX

The following data is part of a premarket notification filed by Morax with the FDA for Hydragel-mini Lipo Kit-pn 4093, Hydragel Lipo Kit-pn 4007, Hydragel Lipo Maxi Kit-pn 4207.

Pre-market Notification Details

Device IDK974854
510k NumberK974854
Device Name:HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207
ClassificationElectrophoretic Separation, Lipoproteins
Applicant MORAX 13805 WATERLOO RD. Chelsea,  MI  48118
ContactBorek Janik
CorrespondentBorek Janik
MORAX 13805 WATERLOO RD. Chelsea,  MI  48118
Product CodeJHO  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-29
Decision Date1998-10-07
Summary:summary

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