FDA.reportPublic FDA data

510(k) K003941

Device
ELECSYS HCG STAT CLASET II
Applicant
ROCHE DIAGNOSTICS CORP.
510(k) number
K003941
Product code
JIS  
Decision
Substantially Equivalent (SESE)
Decision date
2001-01-25
Date received
2000-12-21
Regulation
862.1150
Classification name
Calibrator, Primary
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KAY A TAYLOR
Address
9115 Hague Rd., P.O. Box 50457 Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JIS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories Limited2012-08-14
K061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.2006-05-31
K060266DIMENSION IRON CALIBRATORDade Behring, Inc.2006-03-09
K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.2005-12-23
K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.2003-11-07
K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB2003-10-21
K032296VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORSOrtho-Clinical Diagnostics, Inc.2003-08-13
K030964CALIBRATION PLASMA LMW HEPARINInstrumentation Laboratory CO2003-06-06
K030546CRP (II) CALIBRATORSDenka Seiken Co., Ltd.2003-06-02
K030320WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SETWako Chemicals USA, Inc.2003-04-11
K022682RANDOX C-REACTIVE PROTEIN CALIBRATORRandox Laboratories, Ltd.2002-11-05
K022901VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORSOrtho-Clinical Diagnostics2002-09-27
K013126N LP(A) STANDARD SYDade Behring, Inc.2001-11-09
K012878THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609Thermo Dma, Inc.2001-10-16
K011568RANDOX LIPOPROTEINRandox Laboratories, Ltd.2001-09-28

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases