SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452

Electrophoretic, Lactate Dehydrogenase Isoenzymes

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife Ld Vis Isoenzyme Kit, Models 3450, 3451, And 3452.

Pre-market Notification Details

Device IDK020467
510k NumberK020467
Device Name:SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
ClassificationElectrophoretic, Lactate Dehydrogenase Isoenzymes
Applicant HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
ContactPatricia Franks
CorrespondentPatricia Franks
HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
Product CodeCFE  
CFR Regulation Number862.1445 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-12
Decision Date2002-03-29

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