Cleared Traditional

MICROSPORIDIUM CONTROL SLIDE

K924893 · Scientific Device Laboratory, Inc. · Microbiology
Jan 1993
Decision
109d
Days
Class 1
Risk

About This 510(k) Submission

K924893 is an FDA 510(k) clearance for the MICROSPORIDIUM 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 January 15, 1993, 109 days after receiving the submission on September 28, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K924893 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1992
Decision Date January 15, 1993
Days to Decision 109 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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

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