Cleared Traditional

ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER (K894069) - FDA 510(k) Clearance

Class I Chemistry device.

K894069 · Abbott Laboratories · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 1989
Decision
74d
Days
Class 1
Risk

K894069 is an FDA 510(k) clearance for the ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 74 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 Abbott Laboratories devices

Submission Details

510(k) Number K894069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1989
Decision Date August 21, 1989
Days to Decision 74 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
14d faster than avg
Panel avg: 88d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 30
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K894069.
NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM
K900775 · Bio-Rad · Mar 1990
ABBOTT COMMANDER PARALLEL PROCESSING CENTER
K897158 · Abbott Laboratories · Mar 1990
DPC-ROBOSTAT(TM)
K894710 · Diagnostic Products Corp. · Aug 1989
DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM
K893775 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1989
DELTA (TM) ROBOTIC PIPETTOR
K893031 · Diagnostic Products Corp. · Jun 1989
IDS-1600 SAMPLE HANDLING SYSTEM
K883470 · Baxter Healthcare Corp · Dec 1988