Cleared Traditional

MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD

K963036 · Becton Dickinson Microbiology Systems · Microbiology

Oct 1996

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K963036 is an FDA 510(k) clearance for the MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE 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 October 7, 1996, 63 days after receiving the submission on August 5, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K963036 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 1996
Decision Date	October 07, 1996
Days to Decision	63 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