K-number	K943550
Device name	GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
Applicant	Sigma Diagnostics, Inc.
Product code	LCQ
Device class	Class II
Decision date	Nov 17, 1994
Decision	Substantially Equivalent
Regulation	862.3450

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View the full FDA submission: accessdata.fda.gov

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GENTAMICIN FPIA REAGENT SET AND CALIBRATORS

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