Name: Predicase
Price: 199 USD

K-number	K080183
Device name	CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
Applicant	Roche Diagnostics Corp.
Product code	DIF
Device class	Class I
Decision date	Mar 25, 2008
Decision	Substantially Equivalent
Regulation	862.3280

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Source

View the full FDA submission: accessdata.fda.gov

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CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500

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