Cleared Traditional

HARDYCHROM MRSA

K102922 · Hardy Diagnostics · Microbiology
May 2011
Decision
215d
Days
Class 2
Risk

About This 510(k) Submission

K102922 is an FDA 510(k) clearance for the HARDYCHROM MRSA, a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II — Special Controls, product code JSO), submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on May 4, 2011, 215 days after receiving the submission on October 1, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K102922 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2010
Decision Date May 04, 2011
Days to Decision 215 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