K-number	K972586
Device name	AIA-PACK TSH 3RD-GEN ASSAY
Applicant	Tosoh Medics, Inc.
Product code	JLW
Device class	Class II
Decision date	Aug 29, 1997
Decision	Substantially Equivalent
Regulation	862.1690

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View the full FDA submission: accessdata.fda.gov

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AIA-PACK TSH 3RD-GEN ASSAY

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