Cleared Traditional

K862066 - TITERTEK MICROPLATE WASHER S-12

K862066 is the FDA 510(k) clearance for TITERTEK MICROPLATE WASHER S-12 by Flow Laboratories, Inc.. It is a Class 1 Microbiology device (product code JTC) cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K862066 · Flow Laboratories, Inc. · Microbiology device
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Jun 1986
Decision
6d
Days
Class 1
Risk

K862066 is an FDA 510(k) clearance for the TITERTEK MICROPLATE WASHER S-12. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mclean, US). The FDA issued a Cleared decision on June 5, 1986 after a review of 6 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 Flow Laboratories, Inc. devices

Submission Details

510(k) Number K862066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1986
Decision Date June 05, 1986
Days to Decision 6 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
96d faster than avg
Panel avg: 102d · This submission: 6d
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 29
Devices cleared under the same product code (JTC) and FDA review panel - the closest regulatory comparables to K862066.
BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403
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DYNATECH MR 250 MANUAL MICROELISA READER
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MULTI-CHANNEL MICROPIPETTES
K862802 · Dynatech Laboratories, Inc. · Aug 1986
BIO-TEK EL 401 HANDHELD MICROPLATE WASHER
K853920 · Bio-Tek Instruments, Inc. · Oct 1985
TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA
K850908 · Flow Laboratories, Inc. · Mar 1985
BIO-TEK AUTOMATED MICROPLATE WASHER EL402
K850249 · Bio-Tek Instruments, Inc. · Mar 1985