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510(k) K922327

Device
DENLEY WELLPREP 2 SAMPLE PROCESSOR
Applicant
DENLEY INSTRUMENTS, INC.
510(k) number
K922327
Product code
JQW  
Decision
Substantially Equivalent (SESE)
Decision date
1992-08-12
Date received
1992-05-11
Regulation
862.2750
Classification name
Station, Pipetting And Diluting, For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Hematology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOYCE T DAVIS
Address
3 Bethesda Metro Center Suite 750 Bethesda MD US 20814 20814

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JQW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023955BD VIPER INSTRUMENTBecton, Dickinson & CO2003-06-24
K973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.1998-04-30
K9801802700 SAMPLE MANAGERWaters Corporation1998-02-12
K970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.1997-06-30
K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.1997-04-21
K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics1997-03-28
K962859MINI SAMPLE PROCESSORCavro Scientific Instruments, Inc.1996-10-29
K961896MICROLAB 4000, MICROLAB 4200Hamilton Co.1996-08-16
K961694IMPACTMatrix Technologies Corp.1996-06-21
K953345GENESISTecan U.S., Inc.1995-11-21
K951753MEDTEC AUTOBLOT 2000Medtec, Inc.1995-10-17
K952025ROBOCAPPharmacia, Inc.1995-07-26
K9445564 CHANNEL DISPENSERTecan U.S., Inc.1994-10-25
K9426554 CHANNEL DISPENSERTecan U.S., Inc.1994-09-02
K942290STAR I WORKSTATIONStandard Engineering1994-08-26

Legacy Summary#

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FDA Review#

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