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FDA 510(k) Applications Submitted by TAMMY WHARTON
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150502
02/26/2015
DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls
Microgenics Corporation
K080960
04/03/2008
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS
ABBOTT DIABETES CARE INC.
K122053
07/13/2012
SHAPEMATCH CUTTING GUIDE
STRYKER CORP.
K193566
12/23/2019
ZELTIQ CoolSculpting System
ZELTIQ Aesthetics, Inc.
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