K181436

Substantially Equivalent

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test

Applicant: SEKISUI Diagnostics, LLC
Product code: KTN
Advisory panel: Immunology
Date received: 2018-06-01
Decision date: 2018-06-22
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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