Name: Predicase
Price: 199 USD

K-number	K063545
Device name	MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
Applicant	Alfa Scientific Designs, Inc.
Product code	DJG
Device class	Class II
Decision date	May 7, 2007
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE

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