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FDA 510(k) Applications Submitted by Barbara E. Stevens
FDA 510(k) Number
Submission Date
Device Name
Applicant
K201269
05/12/2020
Accula Strep A Test
Mesa Biotech, Inc.
K051231
05/13/2005
VERIFYNOW-P2Y12 ASSAY
ACCUMETRICS, INC.
K181443
05/31/2018
Accula RSV Test
Mesa Biotech, Inc.
K042423
09/07/2004
VERIFYNOW-ASPIRIN ASSAY
ACCUMETRICS, INC.
K954523
09/29/1995
THERMOSCAN INSTANT THERMOMETER MODEL IR-6000
THERMOSCAN, INC.
K171641
06/02/2017
Accula Flu A/Flu B Test
Mesa Biotech, Inc.
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