Name: Predicase
Price: 199 USD

K-number	K182654
Device name	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
Applicant	Safecare Biotech (Hangzhou) Co., Ltd.
Product code	NGG
Device class	Class II
Decision date	Nov 19, 2018
Decision	Substantially Equivalent
Regulation	862.3610

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Source

View the full FDA submission: accessdata.fda.gov

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SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

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