Name: Predicase
Price: 199 USD

K-number	K973784
Device name	TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS
Applicant	Biosite Incorporated
Product code	DKZ
Device class	Class II
Decision date	Dec 3, 1997
Decision	Substantially Equivalent
Regulation	862.3100

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Source

View the full FDA submission: accessdata.fda.gov

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TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS

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