Cleared Traditional

BION DIRECT IDENTIFICATION CONTROL SLIDE

K890616 · Bion Ent., Ltd. · Microbiology
Feb 1989
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K890616 is an FDA 510(k) clearance for the BION DIRECT IDENTIFICATION CONTROL SLIDE, a Quality Control Slides (Class I — General Controls, product code LJG), submitted by Bion Ent., Ltd. (Park Ridge, US). The FDA issued a Cleared decision on February 17, 1989, 10 days after receiving the submission on February 7, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K890616 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 1989
Decision Date February 17, 1989
Days to Decision 10 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LJG — Quality Control Slides
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

Similar Devices — LJG Quality Control Slides

All 26
MICROSPORIDIUM CONTROL SET
K943228 · Meridian Diagnostics, Inc. · Oct 1994
MICROSPORIDIUM CONTROL SLIDE
K924893 · Scientific Device Laboratory, Inc. · Jan 1993
CRYPTOSPORIDIUM CONTROL SLIDE
K890670 · Scientific Device Laboratory, Inc. · Mar 1989
GRAM STAIN CONTROL SLIDE
K890718 · Scientific Device Laboratory, Inc. · Mar 1989
HISTO-CHECK LEGIONELLA CONTROL SLIDES
K883567 · Val Tech Diagnostics, Inc. · Oct 1988
HISTO-CHECK ACID FAST SLIDES
K883568 · Val Tech Diagnostics, Inc. · Oct 1988