Cleared Traditional

HardyCHROM ESBL

K160512 · Hardy Diagnostics · Microbiology
Nov 2016
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K160512 is an FDA 510(k) clearance for the HardyCHROM ESBL, 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 November 15, 2016, 265 days after receiving the submission on February 24, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K160512 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2016
Decision Date November 15, 2016
Days to Decision 265 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