Name: Predicase
Price: 199 USD

K-number	K173127
Device name	skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
Applicant	Skyla Corporation H.S.P.B
Product code	LCP
Device class	Class II
Decision date	Sep 25, 2018
Decision	Substantially Equivalent
Regulation	864.7470

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Source

View the full FDA submission: accessdata.fda.gov

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skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)

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