Cleared Traditional

ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT

K884026 · Oxoid U.S.A., Inc. · Microbiology
Feb 1989
Decision
133d
Days
Class 1
Risk

About This 510(k) Submission

K884026 is an FDA 510(k) clearance for the ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT, a Antisera, All Types, Escherichia Coli (Class I — General Controls, product code GNA), submitted by Oxoid U.S.A., Inc. (Columbia, US). The FDA issued a Cleared decision on February 3, 1989, 133 days after receiving the submission on September 23, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number K884026 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1988
Decision Date February 03, 1989
Days to Decision 133 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GNA — Antisera, All Types, Escherichia Coli
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3255