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510(k) K030320

Device
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
Applicant
WAKO CHEMICALS, USA, INC.
510(k) number
K030320
Product code
JIS  
Decision
Substantially Equivalent (SESE)
Decision date
2003-04-11
Date received
2003-01-30
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
LORI CREASY
Address
1600 Bellwood Rd. Richmond VA US 23237 23237

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
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
K010696BECKMAN COULTER DNASE B CALIBRATORBeckman Coulter, Inc.2001-05-10

Legacy Summary#

summary

FDA Review#

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