Name: Predicase
Price: 199 USD

K-number	K101853
Device name	PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115
Applicant	Diadexus, Inc.
Product code	NOE
Device class	Class II
Decision date	Jan 3, 2011
Decision	Substantially Equivalent
Regulation	866.5600

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Source

View the full FDA submission: accessdata.fda.gov

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PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115

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