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510(k) K150910

ACCU-CHEK Connect Diabetes Management App by Roche Diabetes Care, Inc. — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2015
Date Received
April 3, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Drug Dose
Device Class
Class II
Regulation Number
868.1890
Review Panel
CH
Submission Type

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  • K220364 — Accu-Chek Safe-T-Pro Uno Lancing Device (April 5, 2022)
  • K214022 — Accu-Chek Softclix Blood Lancing System (February 17, 2022)
  • K181131 — Accu-Chek Guide Me Blood Glucose Monitoring System (December 13, 2018)

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