FDA 510(k)

SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...

K-Number: K111429 · 2011-08-18

Decision Date2011-08-18

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... 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 2011-08-18 under 510(k) number K111429. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...?

SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... is a medical device that received FDA 510(k) clearance on 2011-08-18. The listed applicant is Trek Diagnostic Systems, Ltd.. The 510(k) number is K111429.

When did SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... receive FDA 510(k) clearance?

SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... received FDA 510(k) clearance on 2011-08-18, under 510(k) number K111429.

Who is the listed applicant for SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...?

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 (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...?

The FDA product code for SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... is JWY.

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Other records listing Trek Diagnostic Systems, Ltd. as applicant

K110583SENSITITRE OPTIREAD K110331SENSITITRE AIM (TM)K093741SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES K092445SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES K062681SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE K041534SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL

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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.