Cleared Traditional

MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

K062839 · Trek Diagnostic Systems, Inc. · Microbiology
Nov 2006
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K062839 is an FDA 510(k) clearance for the MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Trek Diagnostic Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on November 9, 2006, 49 days after receiving the submission on September 21, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K062839 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2006
Decision Date November 09, 2006
Days to Decision 49 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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