K-number	K981243
Device name	BIOSTRIDE FREE T4 EIA TEST KIT
Applicant	Biostride Diagnostics, Inc.
Product code	CEC
Device class	Class II
Decision date	Jun 29, 1998
Decision	Substantially Equivalent
Regulation	862.1695

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Source

View the full FDA submission: accessdata.fda.gov

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BIOSTRIDE FREE T4 EIA TEST KIT

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