K-number	K930359
Device name	CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
Applicant	Helena Laboratories
Product code	JHT
Device class	Class II
Decision date	Apr 12, 1993
Decision	Substantially Equivalent
Regulation	862.1215

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CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305

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