Name: Predicase
Price: 199 USD

K-number	K132085
Device name	ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
Applicant	Co-Innovation Biotech Co., Ltd.
Product code	LCX
Device class	Class II
Decision date	Nov 12, 2013
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM

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