Cleared Traditional

LYFO(TM) DIFFERIENTAL DISK-PYR

K954812 · Microbiologics, Inc. · Microbiology
Dec 1995
Decision
62d
Days
Class 1
Risk

About This 510(k) Submission

K954812 is an FDA 510(k) clearance for the LYFO(TM) DIFFERIENTAL DISK-PYR, 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 December 20, 1995, 62 days after receiving the submission on October 19, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K954812 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1995
Decision Date December 20, 1995
Days to Decision 62 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