Cleared Traditional

SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES

K062190 · Trek Diagnostic Systems, Inc. · Microbiology
Aug 2006
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K062190 is an FDA 510(k) clearance for the SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES, 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 August 31, 2006, 31 days after receiving the submission on July 31, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K062190 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2006
Decision Date August 31, 2006
Days to Decision 31 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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