Cleared Traditional

K800232 - ABCO ULTRA SLIDE MICROSCOPE SLIDE (FDA 510(k) Clearance)

Class I Pathology device.

K800232 · Abco Dealers, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1980
Decision
16d
Days
Class 1
Risk

K800232 is an FDA 510(k) clearance for the ABCO ULTRA SLIDE MICROSCOPE SLIDE. Classified as Slides, Microscope (product code KEW), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1980 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3010 - the FDA pathology 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 Abco Dealers, Inc. devices

Submission Details

510(k) Number K800232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1980
Decision Date February 21, 1980
Days to Decision 16 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 77d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KEW Slides, Microscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3010
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.