Name: Predicase
Price: 199 USD

K-number	K131236
Device name	UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
Applicant	Ucp Biosciences, Inc.
Product code	LCX
Device class	Class II
Decision date	Nov 7, 2013
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP

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