K-number	K121101
Device name	SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
Applicant	Astoria-Pacific, Inc.
Product code	JIA
Device class	Class I
Decision date	Jun 20, 2013
Decision	Substantially Equivalent
Regulation	862.1310

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View the full FDA submission: accessdata.fda.gov

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SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT

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