Cleared Traditional

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES

K040619 · Trek Diagnostic Systems, Inc. · Microbiology
Apr 2004
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K040619 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 April 7, 2004, 29 days after receiving the submission on March 9, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K040619 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2004
Decision Date April 07, 2004
Days to Decision 29 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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