Plato 3000

FDA 510(k) K933088 · Rosys, Inc.

Substantially Equivalent

510(k) numberK933088

Submission

Device name
Plato 3000
Applicant
Rosys, Inc.
Wilmington, DE, US
Received
June 23, 1993
Decision date
February 25, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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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K023955BD Viper InstrumentJQW · Traditional Becton, Dickinson & CO06/24/2003SE
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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

More from Tecan U.S., Inc.

510(k)DeviceDecision
K943454Plato 3300/1300JJQ · Traditional 01/09/1995SE

Questions and answers

When was Plato 3000 cleared by the FDA?

Plato 3000 (K933088) received a 510(k) decision of Substantially Equivalent on February 25, 1994, 247 days after the submission was received.

What is the product code of K933088?

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.