Cleared Traditional

MUELLER HINTON AGAR WITH 5% SHEEP BLOOD

K960420 · Becton Dickinson Microbiology Systems · Microbiology

Apr 1996

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K960420 is an FDA 510(k) clearance for the MUELLER HINTON AGAR WITH 5% SHEEP BLOOD, a Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (Class II — Special Controls, product code JTZ), submitted by Becton Dickinson Microbiology Systems (Cockeysville, US). The FDA issued a Cleared decision on April 4, 1996, 66 days after receiving the submission on January 29, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K960420 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 1996
Decision Date	April 04, 1996
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

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