Cleared Traditional

K831644 - PIPETTE 12 CHANNEL

K831644 is an FDA 510(k) clearance for PIPETTE 12 CHANNEL, manufactured by Organon Teknika Corp.. The device is a Class 1 Chemistry device with product code JTC cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K831644 · Organon Teknika Corp. · Chemistry device
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Aug 1983
Decision
70d
Days
Class 1
Risk

K831644 is an FDA 510(k) clearance for the PIPETTE 12 CHANNEL. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Organon Teknika Corp. (Mchenry, US). The FDA issued a Cleared decision on August 1, 1983 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2500 - the FDA in vitro diagnostics and chemistry 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 - K831644

510(k) Number K831644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date August 01, 1983
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
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
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DISPOSABLE DISPENSE MANIFOLD
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