Cleared Traditional

DIFCO DIRECTOR INOCULATION SYSTEM

K890339 · Difco Laboratories, Inc. · Microbiology
Feb 1989
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K890339 is an FDA 510(k) clearance for the DIFCO DIRECTOR INOCULATION SYSTEM, a Reagent/device, Inoculum Calibration (Class II — Special Controls, product code LIE), submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on February 7, 1989, 15 days after receiving the submission on January 23, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K890339 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 1989
Decision Date February 07, 1989
Days to Decision 15 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LIE — Reagent/device, Inoculum Calibration
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640