K-number	K932686
Device name	PARAMAX(R) PHENYTOIN REAGENT
Applicant	Baxter Diagnostics, Inc.
Product code	DIP
Device class	Class II
Decision date	Nov 26, 1993
Decision	Substantially Equivalent
Regulation	862.3350

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Source

View the full FDA submission: accessdata.fda.gov

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PARAMAX(R) PHENYTOIN REAGENT

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