FDA 510(k) Applications for Medical Device Product Code "CIC"
(Cresolphthalein Complexone, Calcium)

FDA 510(k) Number Applicant Device Name Decision Date
K991111 A.P. TOTAL CARE, INC. BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 05/25/1999
K050077 ARKRAY, INC. SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS 02/15/2005
K053401 ARKRAY, INC. SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS 03/24/2006
K971907 CAROLINA LIQUID CHEMISTRIES CORP. CALCIUM REAGENT 06/24/1997
K955939 DERMA MEDIA LAB., INC. CALCIUM REAGENT 03/13/1996
K023105 ELAN DIAGNOSTICS ATAC CALCIUM REAGENT AND ATAC CALIBRATOR 03/13/2003
K041009 HEMAGEN DIAGNOSTICS, INC. RAICHEM CALCIUM (OCPC) LIQUID REAGENT 06/25/2004
K130870 HITACHI CHEMICAL DIAGNOSTICS, INC. HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) 05/02/2013
K070249 HORIBA ABX ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H 04/26/2007
K000375 RANDOX LABORATORIES, LTD. RANDOX CALCIUM 04/05/2000
K963292 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS 10/31/1996
K083339 Siemens Healthcare Diagnostics Inc. DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) 03/09/2009
K013652 WIENER LABORATORIES S.A.I.C. WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 12/21/2001


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