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) | Mar 9, 2009 |
| K070249 | Horiba Abx | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONT | Apr 26, 2007 |
| K053401 | Arkray | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | Mar 24, 2006 |
| K050077 | Arkray | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS | Feb 15, 2005 |
| K041009 | Hemagen Diagnostics | RAICHEM CALCIUM (OCPC) LIQUID REAGENT | Jun 25, 2004 |
| K023105 | Elan Diagnostics | ATAC CALCIUM REAGENT AND ATAC CALIBRATOR | Mar 13, 2003 |
| K013652 | Wiener Laboratories Saic | WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 | Dec 21, 2001 |
| K000375 | Randox Laboratories | RANDOX CALCIUM | Apr 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 | Jun 24, 1997 |
| K963292 | Roche Diagnostic Systems | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | Oct 31, 1996 |
| K955939 | Derma Media Lab | CALCIUM REAGENT | Mar 13, 1996 |
| K944258 | Olympus America | CALCIUM REAGENT | Jan 5, 1995 |
| K931362 | Instrumentation Laboratory | IL TEST CALCIUM | Feb 1, 1994 |
| K932158 | Em Diagnostic Systems | CALCIUM TEST ITEM NUMBER 65409 | Sep 27, 1993 |
| K924435 | Olympus | OLYMPUS CALCIUM REAGENT | Oct 19, 1992 |
| K923034 | Heraeus Kulzer | MILES URINE CALCIUM METHOD | Sep 15, 1992 |
| K922233 | Olympus | OLYMPUS CALCIUM REAGENT | Jul 10, 1992 |
| K921625 | Pointe Scientific, Inc | CALCIUM-ARSENAZO III REAGENT SET | May 13, 1992 |