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FDA 510(k)

SENSITITRE OPTIREAD

K-Number: K110583 · 2011-09-22

ApplicantTrek Diagnostic Systems, Ltd.
Decision Date2011-09-22
Product CodeLRG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE OPTIREAD 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 2011-09-22 under 510(k) number K110583. The device is classified under product code LRG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSITITRE OPTIREAD?

SENSITITRE OPTIREAD is a medical device that received FDA 510(k) clearance on 2011-09-22. The listed applicant is Trek Diagnostic Systems, Ltd.. The 510(k) number is K110583.

When did SENSITITRE OPTIREAD receive FDA 510(k) clearance?

SENSITITRE OPTIREAD received FDA 510(k) clearance on 2011-09-22, under 510(k) number K110583.

Who is the listed applicant for SENSITITRE OPTIREAD?

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 OPTIREAD?

The FDA product code for SENSITITRE OPTIREAD is LRG.

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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.

K111429SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...K110331SENSITITRE AIM (TM)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: LRG)

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.

K191918Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK191914Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK103532AUTOREADER 2Trek Diagnostic SystemsK111677MICROSCAN(R) MICROSTREP PLUS(R)Siemens Healthcare Diagnostics, Inc.K111205MICROSCAN (R) MICROSTREP PLUS (R) PANELSSiemens Healthcare Diagnostics, Inc.K101425MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIESSiemens Healthcare Diagnostics

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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