Name: Predicase
Price: 199 USD

K-number	K172627
Device name	David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
Applicant	Runbio Biotech Co.,Ltd
Product code	LCX
Device class	Class II
Decision date	Mar 28, 2018
Decision	Substantially Equivalent
Regulation	862.1155

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette

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