Cleared Traditional

DRYSPOT E.COLI 0157 KIT

K993401 · Oxoid , Ltd. · Microbiology
Feb 2000
Decision
143d
Days
Class 1
Risk

About This 510(k) Submission

K993401 is an FDA 510(k) clearance for the DRYSPOT E.COLI 0157 KIT, a Antisera, All Types, Escherichia Coli (Class I — General Controls, product code GNA), submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on February 28, 2000, 143 days after receiving the submission on October 8, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number K993401 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 1999
Decision Date February 28, 2000
Days to Decision 143 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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