Genesis

FDA 510(k) K953345 · Tecan U.S., Inc.

Substantially Equivalent

510(k) numberK953345

Submission

Device name
Genesis
Applicant
Tecan U.S., Inc.
Research Triangle Park, NC, US
Received
July 12, 1995
Decision date
November 21, 1995
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

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
K951753Medtec Autoblot 2000JQW · Traditional Medtec, Inc.10/17/1995SE

More from Medtec, Inc.

510(k)DeviceDecision
K963268Genesis RMPJRA · Traditional 03/18/1997SE
K9445564 Channel DispenserJQW · Traditional 10/25/1994SE
K9426554 Channel DispenserJQW · Traditional 09/02/1994SE
K933996ProfiblotKPA · Traditional 01/28/1994SE
K915492RSP Mega Sample ProcessorJQW · Traditional 02/21/1992SE
K912036Robotic Sample ProcessorJQW · Traditional 07/26/1991SE
K910740SLT Microplate WasherJJQ · Traditional 03/27/1991SE
K894126Robotic Sample ProcessorJQW · Traditional 08/15/1989SE
K854406Tecan Robotic Sample Processor(Rsp) #500JQW · Traditional 02/10/1986SE

Questions and answers

When was Genesis cleared by the FDA?

Genesis (K953345) received a 510(k) decision of Substantially Equivalent on November 21, 1995, 132 days after the submission was received.

What is the product code of K953345?

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.