Cleared Traditional

GRAM STAIN CONTROL SLIDE

K890718 · Scientific Device Laboratory, Inc. · Microbiology
Mar 1989
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K890718 is an FDA 510(k) clearance for the GRAM STAIN CONTROL SLIDE, a Quality Control Slides (Class I — General Controls, product code LJG), submitted by Scientific Device Laboratory, Inc. (Glenview, US). The FDA issued a Cleared decision on March 16, 1989, 31 days after receiving the submission on February 13, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K890718 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 1989
Decision Date March 16, 1989
Days to Decision 31 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

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