Cleared Traditional

LYFO(TM) DIFFERENTIAL DISK-BACITRACIN

K970009 · Microbiologics, Inc. · Microbiology
Feb 1997
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K970009 is an FDA 510(k) clearance for the LYFO(TM) DIFFERENTIAL DISK-BACITRACIN, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Microbiologics, Inc. (St. Cloud, US). The FDA issued a Cleared decision on February 6, 1997, 35 days after receiving the submission on January 2, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K970009 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 1997
Decision Date February 06, 1997
Days to Decision 35 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