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FDA 510(k)

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

K-Number: K181436 · 2018-06-22

ApplicantSEKISUI Diagnostics, LLC
Decision Date2018-06-22
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test is a medical device manufactured by SEKISUI Diagnostics, LLC. It received FDA 510(k) clearance on 2018-06-22 under approval number K181436. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test?

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test is a medical device that received FDA 510(k) clearance on 2018-06-22. It is manufactured by SEKISUI Diagnostics, LLC. The 510(k) number is K181436.

When was OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test approved by the FDA?

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test received FDA 510(k) clearance on 2018-06-22, under approval number K181436.

What company makes OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test?

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test is manufactured by SEKISUI Diagnostics, LLC.

What is the FDA product code for OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test?

The FDA product code for OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test is KTN.

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Related PubMed Literature

PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41815749 The history of state preemption and medical device regulation: lessons for artificial intelligence oversight. Health affairs scholar (2026) PMID: 40794850 Regulatory Approved Point-of-Care Diagnostics (FDA & Health Canada): A Comprehensive Framework for Analytical Validity, Clinical Validity, and Clinical Utility in Medical Devices. The journal of applied laboratory medicine (2025) PMID: 40706113 RNA aptamer-packaged virus-like particles for label-free, rapid, and on-site fluorescence detection of malachite green in aquatic products. Biosensors & bioelectronics (2025)

Other Devices by SEKISUI Diagnostics, LLC

K182001Acucy Influenza A&B Test with the Acucy System K192719Osom Ultra Plus Flu A&B Test Kit K241188Acucy® Influenza A&B Test with the Acucy® 2 System

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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