REP FLUR CHOLESTEROL-60 KIT

Electrophoretic Separation, Lipoproteins

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep Flur Cholesterol-60 Kit.

Pre-market Notification Details

Device IDK964471
510k NumberK964471
Device Name:REP FLUR CHOLESTEROL-60 KIT
ClassificationElectrophoretic Separation, Lipoproteins
Applicant HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
ContactPat Franks
CorrespondentPat Franks
HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
Product CodeJHO  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-07
Decision Date1996-12-23

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