Name: Predicase
Price: 199 USD

K-number	K210327
Device name	First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup
Applicant	W.H.P.M., Inc.
Product code	QBF
Device class	Class II
Decision date	Aug 12, 2021
Decision	Substantially Equivalent
Regulation	862.3700

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup

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