REP ALP-15, 8, & 4 KITS

Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep Alp-15, 8, & 4 Kits.

Pre-market Notification Details

Device IDK912603
510k NumberK912603
Device Name:REP ALP-15, 8, & 4 KITS
ClassificationElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
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 CodeCIN  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-10
Decision Date1991-07-30

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