Cleared Traditional

MUELLER HINTON AGAR W/OXACILLIN

K941985 · Carr-Scarborough Microbiologicals, Inc. · Microbiology

Aug 1994

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K941985 is an FDA 510(k) clearance for the MUELLER HINTON AGAR W/OXACILLIN, a Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (Class II — Special Controls, product code JTZ), submitted by Carr-Scarborough Microbiologicals, Inc. (Stone Mountain, US). The FDA issued a Cleared decision on August 24, 1994, 121 days after receiving the submission on April 25, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K941985 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 25, 1994
Decision Date	August 24, 1994
Days to Decision	121 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