Cleared Traditional

LISTERIA SELECTIVE ENRICHMENT MEDIUM

K891593 · Oxoid U.S.A., Inc. · Microbiology
Jun 1989
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K891593 is an FDA 510(k) clearance for the LISTERIA SELECTIVE ENRICHMENT MEDIUM, a Culture Media, Selective And Differential (Class I — General Controls, product code JSI), submitted by Oxoid U.S.A., Inc. (Columbia, US). The FDA issued a Cleared decision on June 9, 1989, 81 days after receiving the submission on March 20, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K891593 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1989
Decision Date June 09, 1989
Days to Decision 81 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSI — Culture Media, Selective And Differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2360