Name: Predicase
Price: 199 USD

K-number	K123050
Device name	EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
Applicant	Nantong Biotechnology Co., Ltd.
Product code	LCX
Device class	Class II
Decision date	Feb 5, 2013
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)

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