Cleared Traditional

MUELLER HINTON AGAR

K132491 · Edge Biologicals, Inc. · Microbiology

Jun 2014

Decision

326d

Days

Class 2

Risk

About This 510(k) Submission

K132491 is an FDA 510(k) clearance for the MUELLER HINTON AGAR, a Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (Class II — Special Controls, product code JTZ), submitted by Edge Biologicals, Inc. (Memphis, US). The FDA issued a Cleared decision on June 30, 2014, 326 days after receiving the submission on August 8, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K132491 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2013
Decision Date	June 30, 2014
Days to Decision	326 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

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