Cleared Traditional

K881112 - FUNGI HISTOLOGY CONTROL SLIDES

K881112 is the FDA 510(k) clearance for FUNGI HISTOLOGY CONTROL SLIDES by Sigma Diagnostics, Inc.. It is a Class 1 Microbiology device (product code LJG) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K881112 · Sigma Diagnostics, Inc. · Microbiology device
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Apr 1988
Decision
37d
Days
Class 1
Risk

K881112 is an FDA 510(k) clearance for the FUNGI HISTOLOGY CONTROL SLIDES. Classified as Quality Control Slides (product code LJG), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 37 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K881112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1988
Decision Date April 21, 1988
Days to Decision 37 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 102d · This submission: 37d
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 7
Devices cleared under the same product code (LJG) and FDA review panel - the closest regulatory comparables to K881112.
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
PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES
K881108 · Sigma Diagnostics, Inc. · Apr 1988
LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES
K881110 · Sigma Diagnostics, Inc. · Apr 1988
INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES
K881107 · Sigma Diagnostics, Inc. · Mar 1988