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FDA 510(k) Applications Submitted by Sekisui Diagnostics, LLC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K121397
05/09/2012
OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
SEKISUI DIAGNOSTICS, LLC
K123182
10/10/2012
OSOM INFLUENZA A&B TEST MODEL 190
SEKISUI DIAGNOSTICS, LLC
K192719
09/26/2019
Osom Ultra Plus Flu A&B Test Kit
Sekisui Diagnostics, LLC
K181436
06/01/2018
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
Sekisui Diagnostics, LLC
K182001
07/26/2018
Acucy Influenza A&B Test with the Acucy System
Sekisui Diagnostics, LLC
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