Name: Predicase
Price: 199 USD

K-number	K111999
Device name	HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
Applicant	Healgen Scientific,, LLC
Product code	JIO
Device class	Class II
Decision date	Apr 17, 2012
Decision	Substantially Equivalent
Regulation	864.6550

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Source

View the full FDA submission: accessdata.fda.gov

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HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL

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