FDA 510(k)

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL

K-Number: K041534 · 2004-07-27

Decision Date2004-07-27

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL 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 2004-07-27 under 510(k) number K041534. 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 HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL?

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL is a medical device that received FDA 510(k) clearance on 2004-07-27. The listed applicant is Trek Diagnostic Systems, Ltd.. The 510(k) number is K041534.

When did SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL receive FDA 510(k) clearance?

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL received FDA 510(k) clearance on 2004-07-27, under 510(k) number K041534.

Who is the listed applicant for SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL?

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 HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL?

The FDA product code for SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL is JWY.

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Other records listing Trek Diagnostic Systems, Ltd. as applicant

K110583SENSITITRE OPTIREAD 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 PLATES K092445SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES K062681SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

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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.