Mini Sampler Processor

FDA 510(k) K970616 · Cavro Scientific Instruments, Inc.

Substantially Equivalent

510(k) numberK970616

Submission

Device name
Mini Sampler Processor
Applicant
Cavro Scientific Instruments, Inc.
Sunnyvale, CA, US
Received
February 18, 1997
Decision date
April 21, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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
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
K951753Medtec Autoblot 2000JQW · Traditional Medtec, Inc.10/17/1995SE

More from Medtec, Inc.

510(k)DeviceDecision
K962859Mini Sample ProcessorJQW · Traditional 10/29/1996SE
K822208Cavro IQ-190 Sample ProcessorJQW · Traditional 08/27/1982SE

Questions and answers

When was Mini Sampler Processor cleared by the FDA?

Mini Sampler Processor (K970616) received a 510(k) decision of Substantially Equivalent on April 21, 1997, 62 days after the submission was received.

What is the product code of K970616?

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.