Cleared Traditional

B-L RED(TM) DISCS

K950346 · Oxis Intl., Inc. · Microbiology
May 1995
Decision
98d
Days
Class 1
Risk

About This 510(k) Submission

K950346 is an FDA 510(k) clearance for the B-L RED(TM) DISCS, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on May 5, 1995, 98 days after receiving the submission on January 27, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K950346 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 1995
Decision Date May 05, 1995
Days to Decision 98 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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