Cleared Traditional

K862112 - MICROSCOPE SLIDES

K862112 is the FDA 510(k) clearance for MICROSCOPE SLIDES by Abco Dealers, Inc.. It is a Class 1 Microbiology device (product code LIB) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K862112 · Abco Dealers, Inc. · Microbiology device
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Jun 1986
Decision
10d
Days
Class 1
Risk

K862112 is an FDA 510(k) clearance for the MICROSCOPE SLIDES. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Milwaukee, US). The FDA issued a Cleared decision on June 13, 1986 after a review of 10 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 Abco Dealers, Inc. devices

Submission Details

510(k) Number K862112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1986
Decision Date June 13, 1986
Days to Decision 10 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
92d faster than avg
Panel avg: 102d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
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 - LIB Device, General Purpose, Microbiology, Diagnostic

All 13
Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K862112.
GULL ELISAWARE
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CORNING EASY WASH ELISA PLATES
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CORNING ELISA PLATES
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IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES
K854423 · Dynatech Laboratories, Inc. · Nov 1985
READER MICROELISA SYSTEM
K831641 · Organon Teknika Corp. · Aug 1983
HEATING BLOCK MICROELISA SYSTEM
K831642 · Organon Teknika Corp. · Jul 1983