Name: Predicase
Price: 199 USD

K-number	K071930
Device name	ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C
Applicant	Blue Cross Bio-Medical Co., Ltd.
Product code	LCX
Device class	Class II
Decision date	Dec 18, 2007
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 URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C

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