Cleared Traditional

K891766 - GENETIC SYSTEMS MICROPLATE STRIP WASHER

K891766 is the FDA 510(k) clearance for GENETIC SYSTEMS MICROPLATE STRIP WASHER by Genetic Systems Corp.. It is a Class 1 Microbiology device (product code JTC) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K891766 · Genetic Systems Corp. · Microbiology device
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May 1989
Decision
38d
Days
Class 1
Risk

K891766 is an FDA 510(k) clearance for the GENETIC SYSTEMS MICROPLATE STRIP WASHER. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Genetic Systems Corp. (Seattle, US). The FDA issued a Cleared decision on May 1, 1989 after a review of 38 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 Genetic Systems Corp. devices

Submission Details

510(k) Number K891766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1989
Decision Date May 01, 1989
Days to Decision 38 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 102d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 30
Devices cleared under the same product code (JTC) and FDA review panel - the closest regulatory comparables to K891766.
IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM
K894645 · Dynatech Laboratories, Inc. · Oct 1989
WASHER 500 MICROELISA SYSTEM
K884695 · Organon Teknika Corp. · Dec 1988
BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403
K884125 · Bio-Tek Instruments, Inc. · Dec 1988
DYNATECH MR 250 MANUAL MICROELISA READER
K874598 · Dynatech Laboratories, Inc. · Nov 1987
MULTI-CHANNEL MICROPIPETTES
K862802 · Dynatech Laboratories, Inc. · Aug 1986
TITERTEK MICROPLATE WASHER S-12
K862066 · Flow Laboratories, Inc. · Jun 1986