Cleared Traditional

K884695 - WASHER 500 MICROELISA SYSTEM

K884695 is an FDA 510(k) clearance for WASHER 500 MICROELISA SYSTEM, manufactured by Organon Teknika Corp.. The device is a Class 1 Microbiology device with product code JTC cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K884695 · Organon Teknika Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
34d
Days
Class 1
Risk

K884695 is an FDA 510(k) clearance for the WASHER 500 MICROELISA SYSTEM. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on December 13, 1988 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2500 - 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K884695

510(k) Number K884695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1988
Decision Date December 13, 1988
Days to Decision 34 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
68d faster than avg
Panel avg: 102d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

JTC Device Classification - Class 1, General Controls

Product Code JTC Device, Microtiter Diluting/dispensing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2500
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 - JTC Device, Microtiter Diluting/dispensing

All 36
Devices cleared under the same product code (JTC) and FDA review panel - the closest regulatory comparables to K884695.
IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM
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MULTI-CHANNEL MICROPIPETTES
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K862066 · Flow Laboratories, Inc. · Jun 1986
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K853920 · Bio-Tek Instruments, Inc. · Oct 1985