K-number	K950028
Device name	PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
Applicant	Sigma Diagnostics, Inc.
Product code	LFT
Device class	Class II
Decision date	Mar 21, 1995
Decision	Substantially Equivalent
Regulation	862.3680

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View the full FDA submission: accessdata.fda.gov

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PRIMIDONE FPIA REAGENT SET AND CALIBRATORS

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