K-number	K990263
Device name	IMMUNOCARD STAT! E. COLI O157:H7
Applicant	Meridian Diagnostics, Inc.
Product code	GMZ
Device class	Class I
Decision date	Aug 9, 1999
Decision	Substantially Equivalent
Regulation	866.3255

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IMMUNOCARD STAT! E. COLI O157:H7

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