K-number	K042357
Device name	IDI-MRSA ASSAY
Applicant	Infectio Diagnostic (I.D.I.), Inc.
Product code	NQX
Device class	Class II
Decision date	Oct 22, 2004
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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IDI-MRSA ASSAY

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