Cleared Traditional

MULLER HINTON BROTH

K880105 · Hardy Media · Microbiology

Mar 1988

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K880105 is an FDA 510(k) clearance for the MULLER HINTON BROTH, a Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (Class II — Special Controls, product code JTZ), submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on March 30, 1988, 84 days after receiving the submission on January 6, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K880105 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 1988
Decision Date	March 30, 1988
Days to Decision	84 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