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FDA 510(k) Application Details - K223352
Device Classification Name
Lancet, Blood
More FDA Info for this Device
510(K) Number
K223352
Device Name
Lancet, Blood
Applicant
Accriva Diagnostics, Inc.
6260 Sequence Drive
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Wenni Haley
Other 510(k) Applications for this Contact
Regulation Number
878.4800
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Classification Product Code
FMK
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More FDA Info for this Product Code
Date Received
11/02/2022
Decision Date
03/02/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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