OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test— 510(k) K181436

Name: FDA 510(k) clearance K181436
Creator: U.S. Food and Drug Administration
Published: 2018-06-22

Substantially Equivalent

SEKISUI Diagnostics, LLC

FDA 510(k) clearance K181436 for OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test, Substantially Equivalent on 2018-06-22. Applicant: SEKISUI Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: SEKISUI Diagnostics, LLC
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 2018-06-01
Decision date: 2018-06-22
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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