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FDA 510(k) Application Details - K214022
Device Classification Name
More FDA Info for this Device
510(K) Number
K214022
Device Name
Accu-Chek Softclix Blood Lancing System
Applicant
Roche Diabetes Care, Inc.
9115 Hague Road
Indianapolis, IN 46250 US
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Contact
Cameron Smith
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QRL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2021
Decision Date
02/17/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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