K-number	K083391
Device name	THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
Applicant	Diagnostic Hybrids, Inc.
Product code	JZO
Device class	Class II
Decision date	May 21, 2009
Decision	Substantially Equivalent
Regulation	866.5870

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View the full FDA submission: accessdata.fda.gov

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THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY

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