Cleared Traditional

SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES

K093741 · Trek Diagnostic Systems, Ltd. · Microbiology
Feb 2010
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K093741 is an FDA 510(k) clearance for the SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Trek Diagnostic Systems, Ltd. (Cleveland, US). The FDA issued a Cleared decision on February 25, 2010, 83 days after receiving the submission on December 4, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K093741 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2009
Decision Date February 25, 2010
Days to Decision 83 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JWY — Manual Antimicrobial Susceptibility Test Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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