Cleared Traditional

LYFO(TM) DIFFERENTIAL DISK-BILE

K945882 · Microbiologics, Inc. · Microbiology
Apr 1995
Decision
144d
Days
Class 1
Risk

About This 510(k) Submission

K945882 is an FDA 510(k) clearance for the LYFO(TM) DIFFERENTIAL DISK-BILE, 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 April 24, 1995, 144 days after receiving the submission on December 1, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K945882 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1994
Decision Date April 24, 1995
Days to Decision 144 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