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JIS — Calibrator, Primary Class II

FDA Device Classification

Classification Details

Product Code
JIS
Device Class
Class II
Regulation Number
862.1150
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K122126randox laboratories limitedDIRECT LDL/HDL CHOLESTEROL CALIBRATORAugust 14, 2012
K061251dade behringDIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORMay 31, 2006
K060266dade behringDIMENSION IRON CALIBRATORMarch 9, 2006
K053104dade behringDIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDecember 23, 2005
K032697dade behringDIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)November 7, 2003
K032608gonotec gesellschaft fuer mess-und regeltechnik mbGONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETEROctober 21, 2003
K032296ortho-clinical diagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORSAugust 13, 2003
K030964instrumentation laboratoryCALIBRATION PLASMA LMW HEPARINJune 6, 2003
K030546denka seiken coCRP (II) CALIBRATORSJune 2, 2003
K030320wako chemicals usaWAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONApril 11, 2003
K022682randox laboratoriesRANDOX C-REACTIVE PROTEIN CALIBRATORNovember 5, 2002
K022901ortho-clinical diagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORSSeptember 27, 2002
K013126dade behringN LP(A) STANDARD SYNovember 9, 2001
K012878thermo dmaTHERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609October 16, 2001
K011568randox laboratoriesRANDOX LIPOPROTEINSeptember 28, 2001
K010696beckman coulterBECKMAN COULTER DNASE B CALIBRATORMay 10, 2001
K003941roche diagnosticsELECSYS HCG STAT CLASET IIJanuary 25, 2001
K003969roche diagnosticsELECSYS CA 125 II CALSETJanuary 12, 2001
K002760roche diagnosticsELECSYS DHEA-S CALSETOctober 5, 2000
K002353roche diagnosticsELECSYS CA 15-3 CALCHECKAugust 10, 2000