Name: Predicase
Price: 199 USD

K-number	K952555
Device name	COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS
Applicant	Roche Diagnostic Systems, Inc.
Product code	MOJ
Device class	Class II
Decision date	Jul 31, 1995
Decision	Substantially Equivalent
Regulation	862.3350

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Source

View the full FDA submission: accessdata.fda.gov

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COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS

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