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FDA 510(k)

THE SENSITITRE AIM

K-Number: K103456 · 2011-06-22

ApplicantTrek Diagnostic Systems
Decision Date2011-06-22
Product CodeLIE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

THE SENSITITRE AIM is the device name listed in this FDA 510(k) record. The listed applicant is Trek Diagnostic Systems. It received FDA 510(k) clearance on 2011-06-22 under 510(k) number K103456. The device is classified under product code LIE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE SENSITITRE AIM?

THE SENSITITRE AIM is a medical device that received FDA 510(k) clearance on 2011-06-22. The listed applicant is Trek Diagnostic Systems. The 510(k) number is K103456.

When did THE SENSITITRE AIM receive FDA 510(k) clearance?

THE SENSITITRE AIM received FDA 510(k) clearance on 2011-06-22, under 510(k) number K103456.

Who is the listed applicant for THE SENSITITRE AIM?

The FDA 510(k) record lists Trek Diagnostic Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE SENSITITRE AIM?

The FDA product code for THE SENSITITRE AIM is LIE.

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 Trek Diagnostic Systems 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.

K112276VIZIONK111615SENSITITRE 18-24 HR SUSCEPTIBILITY PLATESK103532AUTOREADER 2

Related Devices (Code: LIE)

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.

K221493MicroScan Prompt Inoculation System-DBeckman Coulter, Inc.K110331SENSITITRE AIM (TM)Trek Diagnostic Systems, Ltd.K935566SENSI-CAL AMCO AEPA-1Radiometer America, Inc.K911059TURBIDOMETRIC STANDARDScientific Device Laboratory, Inc.K890339DIFCO DIRECTOR INOCULATION SYSTEMDifco Laboratories, Inc.K820299PROMPT INOCULATION SYSTEM3M Company

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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