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510(k) K993022

Device
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
Applicant
BECKMAN COULTER, INC.
510(k) number
K993022
Product code
DLJ  
Decision
Substantially Equivalent (SESE)
Decision date
1999-11-09
Date received
1999-09-09
Regulation
862.3200
Classification name
Calibrators, Drug Specific
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GAIL LEFEBVRE
Address
200 S. Kraemer Blvd.,M/S W-104 Box 8000 Brea CA US 92822 92822

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DLJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.2013-08-08
K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher Scientific2009-07-17
K082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.2008-08-22
K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.2006-09-14
K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.2006-09-06
K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade Behring, Inc.2006-06-22
K060503DIMENSION TACR CALIBRATOR, MODEL DC107Dade Behring, Inc.2006-05-18
K053108DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108Dade Behring, Inc.2006-02-16
K052015DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108Dade Behring, Inc.2005-09-12
K033601LABONE MICRO-PLATE COTININE EIALabone, Inc.2004-02-10
K033246PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORSRoche Diagnostics Corp.2003-12-02
K033165PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORSRoche Diagnostics Corp.2003-10-14
K023780DRI PRIMIDONE CALIBRATORSMicrogenics Corp.2003-02-10
K023316SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLSLin-Zhi International, Inc.2002-12-16
K021449CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLSLin-Zhi International, Inc.2002-06-18

Legacy Summary#

summary

FDA Review#

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