Cleared Traditional

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

K062816 · Trek Diagnostic Systems, Inc. · Microbiology
Nov 2006
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K062816 is an FDA 510(k) clearance for the 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 1, 2006, 42 days after receiving the submission on September 20, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K062816 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2006
Decision Date November 01, 2006
Days to Decision 42 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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