Cleared Traditional

MUELLER HINTON AGAR WITH 2% NACI

K960313 · Remel, L.P. · Microbiology

Mar 1996

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K960313 is an FDA 510(k) clearance for the MUELLER HINTON AGAR WITH 2% NACI, a Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (Class II — Special Controls, product code JTZ), submitted by Remel, L.P. (Lenexa, US). The FDA issued a Cleared decision on March 25, 1996, 63 days after receiving the submission on January 22, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K960313 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 22, 1996
Decision Date	March 25, 1996
Days to Decision	63 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