Name: Predicase
Price: 199 USD

K-number	K020226
Device name	XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03
Applicant	Hellen Professional Services
Product code	JWZ
Device class	Class I
Decision date	Aug 22, 2002
Decision	Substantially Equivalent
Regulation	866.2660

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Source

View the full FDA submission: accessdata.fda.gov

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XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03

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