Cleared Traditional

D'ALA RAPID TEST

K861889 · Pro-Lab, Inc. · Microbiology
Jun 1986
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K861889 is an FDA 510(k) clearance for the D'ALA RAPID TEST, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Pro-Lab, Inc. (Ontario Canada M5m 1c9, CA). The FDA issued a Cleared decision on June 3, 1986, 18 days after receiving the submission on May 16, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K861889 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1986
Decision Date June 03, 1986
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTO — Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660