Accu-Chek FlexLink Plus infusion set

FDA 510(k) Premarket Notification · Submission K143446 · Applicant: Roche Diagnostics GmbH

Public Record 510(k) Submission Decision Date: 2015-08-13 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K143446.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K143446
Applicant / Sponsor
Device Name
Accu-Chek FlexLink Plus infusion set
Product Code
FPA
Decision Date
2015-08-13
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
General Hospital (HO)
Clearance Type
Traditional
Third Party Flag
N
Date Received
2014-12-02

Related Establishments / Registrations

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