Cleared Traditional

SYNERGY QUAD

K941443 · Remel Co. · Microbiology
Sep 1994
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K941443 is an FDA 510(k) clearance for the SYNERGY QUAD, 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 K941443 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 Statement

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