Cleared Traditional

MUELLER HINTON CHOCOLATE AGAR

K850843 · Micro Media Laboratories · Microbiology

Mar 1985

Decision

19d

Days

Class 2

Risk

About This 510(k) Submission

K850843 is an FDA 510(k) clearance for the MUELLER HINTON CHOCOLATE AGAR, a Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (Class II — Special Controls, product code JTZ), submitted by Micro Media Laboratories (San Diego, US). The FDA issued a Cleared decision on March 20, 1985, 19 days after receiving the submission on March 1, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K850843 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 1985
Decision Date	March 20, 1985
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—

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