Abbott Commander Flexible Pipetting Center

FDA 510(k) K894069 · Abbott Laboratories

Substantially Equivalent

510(k) numberK894069

Submission

Device name
Abbott Commander Flexible Pipetting Center
Applicant
Abbott Laboratories
Abbott Park, IL, US
Received
June 8, 1989
Decision date
August 21, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JQW – Station, Pipetting And Diluting, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2750
Specialty
Clinical Chemistry

Other 510(k)s with product code JQW

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K9801802700 Sample ManagerJQW · Traditional Waters Corporation02/12/1998SE
K970420Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional Pharmacia, Inc.06/30/1997SE
K970616Mini Sampler ProcessorJQW · Traditional Cavro Scientific Instruments, Inc.04/21/1997SE
K962687Gio. de Vita E C. S.R.L.(Gdv) Automatic Washing SystemJQW · Traditional Nichols Institute Diagnostics03/28/1997SE
K962859Mini Sample ProcessorJQW · Traditional Cavro Scientific Instruments, Inc.10/29/1996SE
K961896Microlab 4000, Microlab 4200JQW · Traditional Hamilton Co.08/16/1996SE
K961694ImpactJQW · Traditional Matrix Technologies Corp.06/21/1996SE
K953345GenesisJQW · Traditional Tecan U.S., Inc.11/21/1995SE

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Questions and answers

When was Abbott Commander Flexible Pipetting Center cleared by the FDA?

Abbott Commander Flexible Pipetting Center (K894069) received a 510(k) decision of Substantially Equivalent on August 21, 1989, 74 days after the submission was received.

What is the product code of K894069?

The FDA product code is JQW – Station, Pipetting And Diluting, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2750.