Cleared Traditional

HardyCHROM CRE

K190553 · Hardy Diagnostics · Microbiology
Apr 2019
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K190553 is an FDA 510(k) clearance for the HardyCHROM CRE, a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II — Special Controls, product code JSO), submitted by Hardy Diagnostics (Santa Monica, US). The FDA issued a Cleared decision on April 29, 2019, 55 days after receiving the submission on March 5, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K190553 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2019
Decision Date April 29, 2019
Days to Decision 55 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