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FDA 510(k)

SENSITITRE AIM (TM)

K-Number: K110331 · 2011-04-27

ApplicantTrek Diagnostic Systems, Ltd.
Decision Date2011-04-27
Product CodeLIE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE AIM (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Trek Diagnostic Systems, Ltd.. It received FDA 510(k) clearance on 2011-04-27 under 510(k) number K110331. 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 SENSITITRE AIM (TM)?

SENSITITRE AIM (TM) is a medical device that received FDA 510(k) clearance on 2011-04-27. The listed applicant is Trek Diagnostic Systems, Ltd.. The 510(k) number is K110331.

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

SENSITITRE AIM (TM) received FDA 510(k) clearance on 2011-04-27, under 510(k) number K110331.

Who is the listed applicant for SENSITITRE AIM (TM)?

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

What is the FDA product code for SENSITITRE AIM (TM)?

The FDA product code for SENSITITRE AIM (TM) is LIE.

Related Clinical Trials

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Other records listing Trek Diagnostic Systems, Ltd. 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.

K110583SENSITITRE OPTIREADK111429SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...K093741SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATESK092445SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATESK062681SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATEK041534SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL

View all 7 devices →

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.K103456THE SENSITITRE AIMTrek Diagnostic SystemsK935566SENSI-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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