Cleared Traditional

SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...

K111429 · Trek Diagnostic Systems, Ltd. · Microbiology
Aug 2011
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K111429 is an FDA 510(k) clearance for the SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE..., a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Trek Diagnostic Systems, Ltd. (Cleveland, US). The FDA issued a Cleared decision on August 18, 2011, 87 days after receiving the submission on May 23, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K111429 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2011
Decision Date August 18, 2011
Days to Decision 87 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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