Cleared Traditional

HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

K062022 · Trek Diagnostic Systems, Inc. · Microbiology
Sep 2006
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K062022 is an FDA 510(k) clearance for the 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 September 11, 2006, 56 days after receiving the submission on July 17, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K062022 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2006
Decision Date September 11, 2006
Days to Decision 56 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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