Dynatech SPD 3000, #002-900-0000

FDA 510(k) K872363 · Dynatech Laboratories, Inc.

Substantially Equivalent

510(k) numberK872363

Submission

Device name
Dynatech SPD 3000, #002-900-0000
Applicant
Dynatech Laboratories, Inc.
Chantilly, VA, US
Received
June 18, 1987
Decision date
July 16, 1987
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

510(k)DeviceApplicantDecision
K023955BD Viper InstrumentJQW · Traditional Becton, Dickinson & CO06/24/2003SE
K973335Quatro SP Sample Processing Systems (200-499, Inclusive)JQW · Traditional Zenyx Scientific , Ltd.04/30/1998SE
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
K962265MLX Microtiter Plate LuminometerJSE · Traditional 07/25/1996SE
K934111MR7000 with Time Manager Software (TMS)JQP · Traditional 11/02/1994SE
K943701MRX Microplate ReaderJJQ · Traditional 10/20/1994SE
K923456Microlite Microtiter Plate Luminometer ML3000JJQ · Traditional 10/13/1992SE
K915896Microlite Microtiter Plate Luminometer ML2250/MODIJJQ · Traditional 05/04/1992SE
K920888Microlite Microtiter Plate Luminometer ML2200KHO · Traditional 03/19/1992SE
K913590Microlite ML 1000 Microtiter Plate LuminometerJJQ · Traditional 10/25/1991SE
K895313Microlite ML 1000 (Model 3) Microplate LuminometerJJQ · Traditional 10/17/1989SE
K894645Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional 10/17/1989SE
K894687Dynatech MR 5000, Catalog #011-976-0600JJQ · Traditional 08/31/1989SE

Questions and answers

When was Dynatech SPD 3000, #002-900-0000 cleared by the FDA?

Dynatech SPD 3000, #002-900-0000 (K872363) received a 510(k) decision of Substantially Equivalent on July 16, 1987, 28 days after the submission was received.

What is the product code of K872363?

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.