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CIC — Cresolphthalein Complexone, Calcium Class II

FDA Device Classification

Classification Details

Product Code
CIC
Device Class
Class II
Regulation Number
862.1145
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K130870hitachi chemical diagnosticsHITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)May 2, 2013
K083339siemens healthcare diagnosticsDIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)March 9, 2009
K070249horiba abxABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTApril 26, 2007
K053401arkraySPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSMarch 24, 2006
K050077arkraySPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSFebruary 15, 2005
K041009hemagen diagnosticsRAICHEM CALCIUM (OCPC) LIQUID REAGENTJune 25, 2004
K023105elan diagnosticsATAC CALCIUM REAGENT AND ATAC CALIBRATORMarch 13, 2003
K013652wiener laboratories saicWIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002December 21, 2001
K000375randox laboratoriesRANDOX CALCIUMApril 5, 2000
K991111a.p. total careBUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110May 25, 1999
K971907carolina liquid chemistriesCALCIUM REAGENTJune 24, 1997
K963292roche diagnostic systemsCOBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTSOctober 31, 1996
K955939derma media labCALCIUM REAGENTMarch 13, 1996
K944258olympus americaCALCIUM REAGENTJanuary 5, 1995
K931362instrumentation laboratoryIL TEST CALCIUMFebruary 1, 1994
K932158em diagnostic systemsCALCIUM TEST ITEM NUMBER 65409September 27, 1993
K924435olympusOLYMPUS CALCIUM REAGENTOctober 19, 1992
K923034heraeus kulzerMILES URINE CALCIUM METHODSeptember 15, 1992
K922233olympusOLYMPUS CALCIUM REAGENTJuly 10, 1992
K921625pointe scientific, incCALCIUM-ARSENAZO III REAGENT SETMay 13, 1992