Cleared Traditional

K924893 - MICROSPORIDIUM CONTROL SLIDE (FDA 510(k) Clearance)

Class I Microbiology device.

K924893 · Scientific Device Laboratory, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
109d
Days
Class 1
Risk

K924893 is an FDA 510(k) clearance for the MICROSPORIDIUM CONTROL SLIDE. Classified as Quality Control Slides (product code LJG), Class I - General Controls.

Submitted by Scientific Device Laboratory, Inc. (Glenview, US). The FDA issued a Cleared decision on January 15, 1993 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Scientific Device Laboratory, Inc. devices

Submission Details

510(k) Number K924893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 102d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJG Quality Control Slides
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.