Cleared Traditional

K801851 - CENTRIFICHEM PIPETTOR 1000

K801851 is an FDA 510(k) clearance for CENTRIFICHEM PIPETTOR 1000, manufactured by Union Carbide Corp.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K801851 · Union Carbide Corp. · Chemistry device
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Sep 1980
Decision
43d
Days
Class 1
Risk

K801851 is an FDA 510(k) clearance for the CENTRIFICHEM PIPETTOR 1000. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - 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 Union Carbide Corp. devices

FDA 510(k) Submission Details - K801851

510(k) Number K801851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1980
Decision Date September 16, 1980
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 64
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K801851.
IL #781, SEMI-AUTOMATED LOADER
K811696 · Instrumentation Laboratory CO · Jul 1981
MIC-BIOPLATE INOCULATOR
K803092 · Pasco Laboratories, Inc. · Dec 1980
CENTRIFICHEM PIPETTOR ACCURACY CALIB.
K802520 · Union Carbide Corp. · Nov 1980
J.T. BAKER LSA 290 PIPETTER/DILUTER
K801090 · J.T. Baker Chemical Co. · Jun 1980
RIAUSE AUTO PROCESSOR
K801030 · Electro-Nucleonics Laboratories, Inc. · May 1980
MICROMEDIC AUTOMATIC DILUTER
K800606 · Micromedic Systems · Apr 1980