Cleared Traditional

K890718 - GRAM STAIN CONTROL SLIDE

K890718 is the FDA 510(k) clearance for GRAM STAIN CONTROL SLIDE by Scientific Device Laboratory, Inc.. It is a Class 1 Microbiology device (product code LJG) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

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

K890718 is an FDA 510(k) clearance for the GRAM STAIN 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 March 16, 1989 after a review of 31 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scientific Device Laboratory, Inc. devices

Submission Details

510(k) Number K890718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1989
Decision Date March 16, 1989
Days to Decision 31 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 102d · This submission: 31d
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.

Regulatory Peers - LJG Quality Control Slides

All 8
Devices cleared under the same product code (LJG) and FDA review panel - the closest regulatory comparables to K890718.
MICROSPORIDIUM CONTROL SET
K943228 · Meridian Diagnostics, Inc. · Oct 1994
ACID FAST BACILLI HISTOLOGY CONTROL SLIDES
K881106 · Sigma Diagnostics, Inc. · Apr 1988
SPIROCHETES HISTOLOGY CONTROL SLIDES
K881109 · Sigma Diagnostics, Inc. · Apr 1988
FUNGI HISTOLOGY CONTROL SLIDES
K881112 · Sigma Diagnostics, Inc. · Apr 1988
PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES
K881108 · Sigma Diagnostics, Inc. · Apr 1988
LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES
K881110 · Sigma Diagnostics, Inc. · Apr 1988