Cleared Traditional

VERSATREK MYCO PZA KIT

K052323 · Trek Diagnostic Systems, Inc. · Microbiology
Jan 2006
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K052323 is an FDA 510(k) clearance for the VERSATREK MYCO PZA KIT, a Susceptibility Test Powders, Antimycobacterial (Class II — Special Controls, product code MJA), submitted by Trek Diagnostic Systems, Inc. (Sun Prairie, US). The FDA issued a Cleared decision on January 19, 2006, 147 days after receiving the submission on August 25, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K052323 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2005
Decision Date January 19, 2006
Days to Decision 147 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MJA — Susceptibility Test Powders, Antimycobacterial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640