Name: Predicase
Price: 199 USD

K-number	K170587
Device name	On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
Applicant	ACON Laboratories, Inc.
Product code	JIN
Device class	Class I
Decision date	Jul 6, 2017
Decision	Substantially Equivalent
Regulation	862.1435

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Source

View the full FDA submission: accessdata.fda.gov

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On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis

Everything you need for a 510(k) submission. Nothing you don't.