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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