Name: Predicase
Price: 199 USD

K-number	K993961
Device name	RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)
Applicant	American Bio Medica Corp.
Product code	LDJ
Device class	Class II
Decision date	Jan 24, 2000
Decision	Substantially Equivalent
Regulation	862.3870

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Source

View the full FDA submission: accessdata.fda.gov

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RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)

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