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FDA 510(k)

ESENSOR RESPIRATORY VIRAL PANEL

K-Number: K113731 · 2012-09-10

ApplicantClinical Micro Sensors, Inc.
Decision Date2012-09-10
Product CodeJJH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESENSOR RESPIRATORY VIRAL PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Micro Sensors, Inc.. It received FDA 510(k) clearance on 2012-09-10 under 510(k) number K113731. The device is classified under product code JJH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESENSOR RESPIRATORY VIRAL PANEL?

ESENSOR RESPIRATORY VIRAL PANEL is a medical device that received FDA 510(k) clearance on 2012-09-10. The listed applicant is Clinical Micro Sensors, Inc.. The 510(k) number is K113731.

When did ESENSOR RESPIRATORY VIRAL PANEL receive FDA 510(k) clearance?

ESENSOR RESPIRATORY VIRAL PANEL received FDA 510(k) clearance on 2012-09-10, under 510(k) number K113731.

Who is the listed applicant for ESENSOR RESPIRATORY VIRAL PANEL?

The FDA 510(k) record lists Clinical Micro Sensors, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESENSOR RESPIRATORY VIRAL PANEL?

The FDA product code for ESENSOR RESPIRATORY VIRAL PANEL is JJH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Clinical Micro Sensors, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K060543ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800

Related Devices (Code: JJH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960298VIVASPIN 4 10,000 MWVivascience, Inc.K943966VIVAPORE 2Vivascience, Inc.K943965VIVAPORE 10Vivascience, Inc.K941326ULTRAFREE-CLMillipore Corp.K935496NANOSEP N10Intersep , Ltd.K930168CENTRICON -50 CONCENTRATORAmicon, Inc.

Official Source

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

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