510(k) K192719— Osom Ultra Plus Flu A&B Test Kit

Substantially Equivalent

SEKISUI Diagnostics, LLC

Clearance details

Applicant: SEKISUI Diagnostics, LLC
Product code: Code PSZ
Advisory panel: Microbiology
Date received: 2019-09-26
Decision date: 2020-04-03
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: San Diego, CA, US

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