RAPID ELECTROPHORESIS ANALYZER

Electrophoretic Separation, Lipoproteins

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rapid Electrophoresis Analyzer.

Pre-market Notification Details

Device IDK960571
510k NumberK960571
Device Name:RAPID ELECTROPHORESIS ANALYZER
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  
Subsequent Product CodeCEF
Subsequent Product CodeCFE
Subsequent Product CodeCIN
Subsequent Product CodeJBD
Subsequent Product CodeJHX
Subsequent Product CodeJJN
Subsequent Product CodeLCP
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-08
Decision Date1996-10-25

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