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510(k) K832230

Device
DIALYZER PREPARATION SYS DPS-4
Applicant
SERATRONICS, INC.
510(k) number
K832230
Product code
LIF  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-14
Date received
1983-07-11
Regulation
876.5820
Classification name
Dialyzer Reprocessing System
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LIF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux Technologies2010-11-03
K043126ASSIST HEADER CLEANERAlcavis International, Inc.2005-02-03
K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach Company2004-11-15
K033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.2004-04-27
K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLC2003-09-26
K013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International Incorporated2002-07-15
K992016AMUKIN DAmuchina Intl., Inc.2000-01-10
K991851RENACLEAR DIALYZER CLEANING SYSTEMMinntech Corp.1999-08-30
K974426POTENCY TEST STRIPS, INDICATOR TEST STRIPSReprocessing Products Corp1999-02-10
K974798STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPSEnvironmental Test Systems, Inc.1998-03-20
K970799ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)Alexander Mfg. Co.1997-05-14
K955299DPS 4 DIALYZER PREPARATION SYSTEMSeratronics, Inc.1996-10-21
K931336DRS 4 DIALYZER REPROCESSING SYSTEMSeratronics, Inc.1996-04-18
K941867RENALIN REUSE CARTRenal Scientific Service, Inc.1996-01-22
K941757FORMALIN REUSE CARTNational Medical Care, Medical Products Div., Inc.1996-01-22

Legacy Summary#

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FDA Review#

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