Cleared Traditional

RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE

K072827 · Remel, Inc. · Microbiology
Nov 2007
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K072827 is an FDA 510(k) clearance for the RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE, a Culture Media, Antifungal, Susceptibility Test (Class II — Special Controls, product code MJE), submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on November 26, 2007, 54 days after receiving the submission on October 3, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K072827 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2007
Decision Date November 26, 2007
Days to Decision 54 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MJE — Culture Media, Antifungal, Susceptibility Test
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1700