K-number	K955873
Device name	ACS PHENYTOIN ASSAY
Applicant	Ciba Corning Diagnostics Corp.
Product code	LGR
Device class	Class II
Decision date	Mar 11, 1996
Decision	Substantially Equivalent
Regulation	862.3350

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View the full FDA submission: accessdata.fda.gov

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ACS PHENYTOIN ASSAY

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