Cleared Traditional

K951889 - LYFO(TM) DIFFERENTIAL DISK
(FDA 510(k) Clearance)

K951889 · Microbiologics, Inc. · Microbiology
Aug 1995
Decision
122d
Days
Class 1
Risk

K951889 is an FDA 510(k) clearance for the LYFO(TM) DIFFERENTIAL DISK, 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 August 24, 1995, 122 days after receiving the submission on April 24, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K951889 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1995
Decision Date August 24, 1995
Days to Decision 122 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