Cleared Traditional

COLISCREEN

K961191 · Hardy Diagnostics · Microbiology
Jun 1996
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K961191 is an FDA 510(k) clearance for the COLISCREEN, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on June 17, 1996, 83 days after receiving the submission on March 26, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K961191 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1996
Decision Date June 17, 1996
Days to Decision 83 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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