K-number	K981536
Device name	QUANTECH MYOGLOBIN ASSAY
Applicant	Hellen Professional Services
Product code	MVE
Device class	Class II
Decision date	Jun 29, 1998
Decision	Substantially Equivalent
Regulation	866.5680

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View the full FDA submission: accessdata.fda.gov

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QUANTECH MYOGLOBIN ASSAY

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