K-number	K972231
Device name	OSOM MONO TEST 143
Applicant	Wyntek Diagnostics, Inc.
Product code	KTN
Device class	Class II
Decision date	Aug 26, 1997
Decision	Substantially Equivalent
Regulation	866.5640

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View the full FDA submission: accessdata.fda.gov

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OSOM MONO TEST 143

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