Cleared Traditional

UREA AGAR BASE

K881559 · Acumedia Manufacturers, Inc. · Microbiology
Apr 1988
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K881559 is an FDA 510(k) clearance for the UREA AGAR BASE, a Culture Media, Non-selective And Differential (Class I — General Controls, product code JSH), submitted by Acumedia Manufacturers, Inc. (Baltimore, US). The FDA issued a Cleared decision on April 18, 1988, 7 days after receiving the submission on April 11, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number K881559 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1988
Decision Date April 18, 1988
Days to Decision 7 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSH — Culture Media, Non-selective And Differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2320