Product code CIC— Clinical Chemistry
CALCIUM
- Classification name
- Cresolphthalein Complexone, Calcium
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Total cleared
- 99
- First cleared
- Most recent
Market context for product code CIC
FDA has cleared devices under product code CIC between 1976 and 2013, filed by 71 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2013
- 2009
- 2007
- 2006
- 2005
- 2004
- 2003
- 2001
- 2000
- 1999
- 1997
- 1996
- 1995
- 1994
- 1993
Top applicants under product code CIC
Recent clearances under product code CIC
- K130870 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
- K083339 — DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
- K070249 — ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
- K053401 — SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
- K050077 — SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
- K041009 — RAICHEM CALCIUM (OCPC) LIQUID REAGENT
- K023105 — ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
- K013652 — WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
- K000375 — RANDOX CALCIUM
- K991111 — BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02
- K971907 — CALCIUM REAGENT
- K963292 — COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
- K955939 — CALCIUM REAGENT
- K944258 — CALCIUM REAGENT
- K931362 — IL TEST CALCIUM
- K932158 — CALCIUM TEST ITEM NUMBER 65409
- K924435 — OLYMPUS CALCIUM REAGENT
- K923034 — MILES URINE CALCIUM METHOD
- K922233 — OLYMPUS CALCIUM REAGENT
- K921625 — CALCIUM-ARSENAZO III REAGENT SET
- K912027 — CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL
- K905659 — SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
- K903233 — SYNERMED CALCIUM REAGENT KIT
- K903896 — CALCIUM ARSENAZO III REAGENT
- K896224 — COBAS READY CALCIUM REAGENT
- K902479 — CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432
- K901226 — CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)
- K894407 — ABBOTT SPECTRUM(R) CALCIUM REAGENT
- K893778 — CALCIUM TEST ITEM NUMBER: 65409
- K891217 — IQ CALCIUM
- K884599 — TECHNICON RA-100 SYSTEM CALCIUM METHOD
- K884986 — CALCIUM TEST ITEM NUMBER: SR1009
- K884433 — TECHNICON ASSIST(R) CALCIUM METHOD
- K884480 — BIOTROL BILIRUBIN MONOREACTIF
- K882586 — A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM
- K880308 — CALCIUM
- K881054 — CALCIUM, CATALOGUE NUMBER 122-20
- K880845 — CALCIUM REAGENT SET
- K874496 — CALCIUM ASSAY KIT, NUMBER 120-19
- K873519 — PARAMAX CALCIUM REAGENT
- K874131 — CRESOLPHTHALEIN COMPLEXONE, CALCIUM
- K873334 — WAKO(TM) AUTOKIT CALCIUM
- K873697 — MULTICHEM CALCIUM S0910
- K870362 — CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD
- K872306 — SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA)
- K871152 — SIGMA'S CALCIUM PROCEDURE NO. 587
- K871811 — SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)
- K870629 — CALCIUM TEST
- K870170 — EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
- K864661 — UNIFAST CALCIUM TEST
- K864741 — CRESOLPHTHALEIN COMPLEXONE, CALCIUM
- K863670 — VISION (TM) CALCIUM
- K863256 — CALCIUM PROCEDURE
- K863003 — EMDS(TM) CALCIUM TESTPACKS, #67687/95
- K862274 — ANALYST ANALYTICAL TEST ROTORS
- K860664 — CRESOLPHTHALEIN COMPLEXONE, CALCIUM
- K861657 — CALCIUM PROCEDURE
- K860425 — A-GENT LIQUID CALCIUM
- K860044 — CALCIUM (CPC) REAGENT SET
- K855041 — CALCIUM LIQUID STABLE REAGENT SET
- K854716 — NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909
- K853050 — CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ
- K852657 — AMRESCO CALCIUM REAGENT SET
- K852002 — CA BUFFER CA DYE
- K850929 — CALCIUM
- K850281 — CALCIUM
- K844241 — CALCIUM REAGENT FOR DEMAND ANALYZER
- K844243 — TOTAL BILIRUBIN FOR DEMAND ANALYZER
- K843895 — TOTAL CALCIUM REAGENT SET
- K843353 — RAICHEM CALCIUM REAGENT
- K843152 — SYSTEMATE CALCIUM 67214
- K842509 — CALCIUM ASSAY KIT
- K841051 — SERUM CALCIUM REAGENT SET
- K834336 — FLOW-PAC CALCIUM REAGENT SET
- K833035 — CALCIUM DYE REAGENT-CS-718-A/BUFFER
- K832708 — PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS
- K832183 — SANDARE CALCIUM PROCEDURE
- K830238 — ULTRA CHEM CRESOLCAVERSACHEM #65082
- K823756 — ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082
- K823577 — COBAS REAGENT FOR CALCIUM
- K823219 — LIQUIZYME CALCIUM REAGENT SET
- K822469 — PSI CALCIUM REAGENT
- K821196 — SERUM CALCIUM REAGENT SET
- K820241 — WAKO CALCIUM C TEST
- K820090 — ASTRA-T CALCIUM REAGENT
- K812835 — TOTAL CALCIUM REAGENT SET
- K812110 — GILCHEM CALCIUM REAGENT
- K811748 — KING DIAGNOSTICS CALCIUM TEST
- K802923 — BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY
- K802164 — 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM.
- K800680 — REAGENTS FOR DETERM. CALCIUM IN HUMAN
- K792337 — DONNECT. DIAG. CALCIUM DIAG. REAGENT
- K780983 — CALCIUM REAGENT SYSTEM NO. 585
- K771831 — CALCIUM
- K771310 — CALCIUM REAGENT
- K770460 — CENTRIFI CHEM CALCIUM REAGENT
- K770449 — CALCIUM PROCEDURE, TEKPOINT DIRECT
- K760468 — TEST, REFORMULATED HYCEL HMA CALCIUM
- K760475 — REAGENT, CALCIUM DETERMINATION
Data sourced from openFDA. This site is unofficial and independent of the FDA.