CARDIOTRAC CORNING CK ISOENZYME SUBST

Fluorometric Method, Cpk Or Isoenzymes

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Cardiotrac Corning Ck Isoenzyme Subst.

Pre-market Notification Details

Device IDK813573
510k NumberK813573
Device Name:CARDIOTRAC CORNING CK ISOENZYME SUBST
ClassificationFluorometric Method, Cpk Or Isoenzymes
Applicant CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHX  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-12-22
Decision Date1982-01-18

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