Serumax (Automated Serum Centrifugation & Station)

FDA 510(k) K893400 · Medical Robotics

Substantially Equivalent

510(k) numberK893400

Submission

Device name
Serumax (Automated Serum Centrifugation & Station)
Applicant
Medical Robotics
Lexington, KY, US
Received
May 1, 1989
Decision date
June 23, 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

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

Questions and answers

When was Serumax (Automated Serum Centrifugation & Station) cleared by the FDA?

Serumax (Automated Serum Centrifugation & Station) (K893400) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 53 days after the submission was received.

What is the product code of K893400?

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.