K-number	K872346
Device name	SURE-STREP A TEST KIT CATALOG NO. MB-1083
Applicant	Medix Biotech, Inc.
Product code	GTZ
Device class	Class I
Decision date	Sep 30, 1987
Decision	Substantially Equivalent
Regulation	866.3740

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View the full FDA submission: accessdata.fda.gov

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SURE-STREP A TEST KIT CATALOG NO. MB-1083

Everything you need for a 510(k) submission. Nothing you don't.