Cleared Traditional

MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS

K100589 · Bio-Rad · Microbiology
Oct 2010
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K100589 is an FDA 510(k) clearance for the MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS, a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II — Special Controls, product code JSO), submitted by Bio-Rad (Beverly, US). The FDA issued a Cleared decision on October 29, 2010, 241 days after receiving the submission on March 2, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K100589 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2010
Decision Date October 29, 2010
Days to Decision 241 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1700