Cleared Traditional

K945489 - LYFO(TM) DIFFERENTIAL DISK
(FDA 510(k) Clearance)

K945489 · Microbiologics, Inc. · Microbiology

May 1995

Decision

184d

Days

Class 1

Risk

K945489 is an FDA 510(k) clearance for the LYFO(TM) DIFFERENTIAL DISK, a Kit, Anaerobic Identification (Class I — General Controls, product code JSP), submitted by Microbiologics, Inc. (St. Cloud, US). The FDA issued a Cleared decision on May 11, 1995, 184 days after receiving the submission on November 8, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K945489 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 1994
Decision Date	May 11, 1995
Days to Decision	184 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement