SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES— 510(k) K093741

Name: FDA 510(k) clearance K093741
Creator: U.S. Food and Drug Administration
Published: 2010-02-25

Substantially Equivalent

Trek Diagnostic Systems, Ltd.

FDA 510(k) clearance K093741 for SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES, Substantially Equivalent on 2010-02-25. Applicant: Trek Diagnostic Systems, Ltd.. Device class: 2.

Clearance details

Applicant: Trek Diagnostic Systems, Ltd.
Product code: Code JWY
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2009-12-04
Decision date: 2010-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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