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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(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
1f, #8, Dusing Rd.
Hsinchu Science Park
Hsinchu City,  TW 30078
Applicant Contact Cindy Lu
Correspondent
Ivdd Regulatory Consultant
29222 Rancho Viejo Rd.
Suite 218
San Juan Capistrano,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JJE  
Date Received09/29/2017
Decision Date 09/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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