CIC — Cresolphthalein Complexone, Calcium Class II
FDA product code CIC covers "Cresolphthalein Complexone, Calcium", a Class II medical device regulated under 21 CFR 862.1145. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K130870 | hitachi chemical diagnostics | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) | May 2, 2013 |
| K083339 | siemens healthcare diagnostics | DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) | March 9, 2009 |
| K070249 | horiba abx | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONT | April 26, 2007 |
| K053401 | arkray | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | March 24, 2006 |
| K050077 | arkray | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS | February 15, 2005 |
| K041009 | hemagen diagnostics | RAICHEM CALCIUM (OCPC) LIQUID REAGENT | June 25, 2004 |
| K023105 | elan diagnostics | ATAC CALCIUM REAGENT AND ATAC CALIBRATOR | March 13, 2003 |
| K013652 | wiener laboratories saic | WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 | December 21, 2001 |
| K000375 | randox laboratories | RANDOX CALCIUM | April 5, 2000 |
| K991111 | a.p. total care | BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110 | May 25, 1999 |
| K971907 | carolina liquid chemistries | CALCIUM REAGENT | June 24, 1997 |
| K963292 | roche diagnostic systems | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | October 31, 1996 |
| K955939 | derma media lab | CALCIUM REAGENT | March 13, 1996 |
| K944258 | olympus america | CALCIUM REAGENT | January 5, 1995 |
| K931362 | instrumentation laboratory | IL TEST CALCIUM | February 1, 1994 |
| K932158 | em diagnostic systems | CALCIUM TEST ITEM NUMBER 65409 | September 27, 1993 |
| K924435 | olympus | OLYMPUS CALCIUM REAGENT | October 19, 1992 |
| K923034 | heraeus kulzer | MILES URINE CALCIUM METHOD | September 15, 1992 |
| K922233 | olympus | OLYMPUS CALCIUM REAGENT | July 10, 1992 |
| K921625 | pointe scientific, inc | CALCIUM-ARSENAZO III REAGENT SET | May 13, 1992 |