Cleared Traditional

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES

K032382 · Trek Diagnostic Systems, Inc. · Microbiology
Aug 2003
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K032382 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. (Westlake, US). The FDA issued a Cleared decision on August 29, 2003, 28 days after receiving the submission on August 1, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K032382 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2003
Decision Date August 29, 2003
Days to Decision 28 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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