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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