Cleared Traditional

BHI AGAR WITH VANCOMYCIN

K941444 · Remel Co. · Microbiology

Sep 1994

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K941444 is an FDA 510(k) clearance for the BHI AGAR WITH VANCOMYCIN, a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II — Special Controls, product code JSO), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on September 19, 1994, 179 days after receiving the submission on March 24, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K941444 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 1994
Decision Date	September 19, 1994
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

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