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FDA 510(k)

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

K-Number: K173127 · 2018-09-25

ApplicantSkyla Corporation H.S.P.B
Decision Date2018-09-25
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) is a medical device manufactured by Skyla Corporation H.S.P.B. It received FDA 510(k) clearance on 2018-09-25 under approval number K173127. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)?

skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) is a medical device that received FDA 510(k) clearance on 2018-09-25. It is manufactured by Skyla Corporation H.S.P.B. The 510(k) number is K173127.

When was skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) approved by the FDA?

skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) received FDA 510(k) clearance on 2018-09-25, under approval number K173127.

What company makes skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)?

skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) is manufactured by Skyla Corporation H.S.P.B.

What is the FDA product code for skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)?

The FDA product code for skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) is LCP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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