K-number	K022504
Device name	IDI-STREP B ASSAY
Applicant	Infectio Diagnostic, Inc.
Product code	NJR
Device class	Class I
Decision date	Nov 18, 2002
Decision	Substantially Equivalent
Regulation	866.3740

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View the full FDA submission: accessdata.fda.gov

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IDI-STREP B ASSAY

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