Cleared Traditional

E. COLI 0157 LATEX TEST

K903714 · Pro-Lab, Inc. · Microbiology
Jan 1991
Decision
163d
Days
Class 1
Risk

About This 510(k) Submission

K903714 is an FDA 510(k) clearance for the E. COLI 0157 LATEX TEST, a Antisera, All Types, Escherichia Coli (Class I — General Controls, product code GNA), submitted by Pro-Lab, Inc. (Round Rock, US). The FDA issued a Cleared decision on January 24, 1991, 163 days after receiving the submission on August 14, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number K903714 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1990
Decision Date January 24, 1991
Days to Decision 163 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