Name: Predicase
Price: 199 USD

K-number	K874456
Device name	CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT
Applicant	Tm & M C/O Burditt,Bowles,Radzius & Ruberry, Ltd.
Product code	LIO
Device class	Class I
Decision date	Nov 24, 1987
Decision	Substantially Equivalent
Regulation	866.2900

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Source

View the full FDA submission: accessdata.fda.gov

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CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT

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