Name: Predicase
Price: 199 USD

K-number	K043167
Device name	PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X
Applicant	Phamatech, Inc.
Product code	JXM
Device class	Class II
Decision date	Dec 29, 2004
Decision	Substantially Equivalent
Regulation	862.3170

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Source

View the full FDA submission: accessdata.fda.gov

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PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X

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