REP E-Z CK-30 ISOENZYME KIT

Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep E-z Ck-30 Isoenzyme Kit.

Pre-market Notification Details

Device IDK925801
510k NumberK925801
Device Name:REP E-Z CK-30 ISOENZYME KIT
ClassificationNad Reduction/nadh Oxidation, Cpk Or 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 CodeCGS  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-16
Decision Date1992-12-28

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