REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278

Electrophoretic, Protein Fractionation

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep Spe Hi-res Template System, Cat 3276/3277/3278.

Pre-market Notification Details

Device IDK930317
510k NumberK930317
Device Name:REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278
ClassificationElectrophoretic, Protein Fractionation
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 CodeCEF  
CFR Regulation Number862.1630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-22
Decision Date1993-08-03

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