FDA Product Code
FDA Product Code CIC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1145
510(k) Clearances — 99 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K130870 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) | Hitachi Chemical Diagnostics, Inc. | 2013-05-02 | Traditional | PDF ↗ |
| K083339 | DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) | Siemens Healthcare Diagnostics, Inc. | 2009-03-09 | Traditional | PDF ↗ |
| K070249 | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H | Horiba Abx | 2007-04-26 | Traditional | PDF ↗ |
| K053401 | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | Arkray, Inc. | 2006-03-24 | Traditional | PDF ↗ |
| K050077 | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS | Arkray, Inc. | 2005-02-15 | Traditional | PDF ↗ |
| K041009 | RAICHEM CALCIUM (OCPC) LIQUID REAGENT | Hemagen Diagnostics, Inc. | 2004-06-25 | Traditional | PDF ↗ |
| K023105 | ATAC CALCIUM REAGENT AND ATAC CALIBRATOR | Elan Diagnostics | 2003-03-13 | Traditional | PDF ↗ |
| K013652 | WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 | Wiener Laboratories Saic | 2001-12-21 | Traditional | PDF ↗ |
| K000375 | RANDOX CALCIUM | Randox Laboratories, Ltd. | 2000-04-05 | Traditional | PDF ↗ |
| K991111 | BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 | A.P. Total Care, Inc. | 1999-05-25 | Traditional | PDF ↗ |
| K971907 | CALCIUM REAGENT | Carolina Liquid Chemistries Corp. | 1997-06-24 | Traditional | PDF ↗ |
| K963292 | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | Roche Diagnostic Systems, Inc. | 1996-10-31 | Traditional | PDF ↗ |
| K955939 | CALCIUM REAGENT | Derma Media Lab., Inc. | 1996-03-13 | Traditional | PDF ↗ |
| K944258 | CALCIUM REAGENT | Olympus America, Inc. | 1995-01-05 | Traditional | PDF ↗ |
| K931362 | IL TEST CALCIUM | Instrumentation Laboratory CO | 1994-02-01 | Traditional | PDF ↗ |
| K932158 | CALCIUM TEST ITEM NUMBER 65409 | Em Diagnostic Systems, Inc. | 1993-09-27 | Traditional | PDF ↗ |
| K924435 | OLYMPUS CALCIUM REAGENT | Olympus Corp. | 1992-10-19 | Traditional | PDF ↗ |
| K923034 | MILES URINE CALCIUM METHOD | Heraeus Kulzer, Inc. | 1992-09-15 | Traditional | PDF ↗ |
| K922233 | OLYMPUS CALCIUM REAGENT | Olympus Corp. | 1992-07-10 | Traditional | PDF ↗ |
| K921625 | CALCIUM-ARSENAZO III REAGENT SET | Pointe Scientific, Inc., | 1992-05-13 | Traditional | PDF ↗ |
| K912027 | CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL | Enzyme Technology, Inc. | 1992-01-30 | Traditional | PDF ↗ |
| K905659 | SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 | Em Diagnostic Systems, Inc. | 1991-01-15 | Traditional | PDF ↗ |
| K903233 | SYNERMED CALCIUM REAGENT KIT | Synermed, Inc. | 1990-10-04 | Traditional | PDF ↗ |
| K903896 | CALCIUM ARSENAZO III REAGENT | Trace Scientific , Ltd. | 1990-09-13 | Traditional | PDF ↗ |
| K896224 | COBAS READY CALCIUM REAGENT | Roche Diagnostic Systems, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K902479 | CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 | Amresco, Inc. | 1990-07-17 | Traditional | PDF ↗ |
| K901226 | CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) | Technicon Instruments Corp. | 1990-04-19 | Traditional | PDF ↗ |
| K894407 | ABBOTT SPECTRUM(R) CALCIUM REAGENT | Abbott Laboratories | 1989-09-25 | Traditional | PDF ↗ |
| K893778 | CALCIUM TEST ITEM NUMBER: 65409 | Em Diagnostic Systems, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K891217 | IQ CALCIUM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-05-03 | Traditional | PDF ↗ |
| K884599 | TECHNICON RA-100 SYSTEM CALCIUM METHOD | Technicon Instruments Corp. | 1989-01-27 | Traditional | PDF ↗ |
| K884986 | CALCIUM TEST ITEM NUMBER: SR1009 | Em Diagnostic Systems, Inc. | 1989-01-13 | Traditional | PDF ↗ |
| K884480 | BIOTROL BILIRUBIN MONOREACTIF | Biotrol, USA, Inc. | 1988-11-29 | Traditional | PDF ↗ |
| K884433 | TECHNICON ASSIST(R) CALCIUM METHOD | Technicon Instruments Corp. | 1988-11-29 | Traditional | PDF ↗ |
| K882586 | A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM | A-Kem, Inc. | 1988-08-08 | Traditional | PDF ↗ |
| K880308 | CALCIUM | Catachem, Inc. | 1988-05-27 | Traditional | PDF ↗ |
| K881054 | CALCIUM, CATALOGUE NUMBER 122-20 | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-18 | Traditional | PDF ↗ |
| K880845 | CALCIUM REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-05 | Traditional | PDF ↗ |
| K874496 | CALCIUM ASSAY KIT, NUMBER 120-19 | Diagnostic Chemicals, Ltd. (Usa) | 1988-02-11 | Traditional | PDF ↗ |
| K873519 | PARAMAX CALCIUM REAGENT | Baxter Healthcare Corp | 1987-12-14 | Traditional | PDF ↗ |
| K874131 | CRESOLPHTHALEIN COMPLEXONE, CALCIUM | Pointe Scientific, Inc., | 1987-12-04 | Traditional | PDF ↗ |
| K873334 | WAKO(TM) AUTOKIT CALCIUM | Wako Chemicals USA, Inc. | 1987-10-02 | Traditional | PDF ↗ |
| K873697 | MULTICHEM CALCIUM S0910 | Simmler, Inc. | 1987-10-02 | Traditional | PDF ↗ |
| K870362 | CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD | Trace Scientific , Ltd. | 1987-08-21 | Traditional | PDF ↗ |
| K872306 | SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA) | Boehringer Mannheim Corp. | 1987-08-18 | Traditional | PDF ↗ |
| K871152 | SIGMA'S CALCIUM PROCEDURE NO. 587 | Sigma Diagnostics, Inc. | 1987-06-12 | Traditional | PDF ↗ |
| K871811 | SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) | Boehringer Mannheim Corp. | 1987-05-26 | Traditional | PDF ↗ |
| K870629 | CALCIUM TEST | Sclavo, Inc. | 1987-04-29 | Traditional | PDF ↗ |
| K870170 | EASY-TEST CALCIUM (CA), ITEM NO. 67528/93 | Em Diagnostic Systems, Inc. | 1987-03-06 | Traditional | PDF ↗ |
| K864661 | UNIFAST CALCIUM TEST | Sclavo, Inc. | 1987-02-04 | Traditional | PDF ↗ |
| K864741 | CRESOLPHTHALEIN COMPLEXONE, CALCIUM | Tech-Co, Inc. | 1987-01-09 | Traditional | PDF ↗ |
| K863670 | VISION (TM) CALCIUM | Abbott Laboratories | 1986-11-13 | Traditional | PDF ↗ |
| K863256 | CALCIUM PROCEDURE | Data Medical Associates, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K863003 | EMDS(TM) CALCIUM TESTPACKS, #67687/95 | Em Diagnostic Systems, Inc. | 1986-09-16 | Traditional | PDF ↗ |
| K862274 | ANALYST ANALYTICAL TEST ROTORS | E.I. Dupont DE Nemours & Co., Inc. | 1986-07-29 | Traditional | PDF ↗ |
| K860664 | CRESOLPHTHALEIN COMPLEXONE, CALCIUM | Amresco, Inc. | 1986-06-27 | Traditional | PDF ↗ |
| K861657 | CALCIUM PROCEDURE | Data Medical Associates, Inc. | 1986-05-29 | Traditional | PDF ↗ |
| K860425 | A-GENT LIQUID CALCIUM | Abbott Laboratories | 1986-04-03 | Traditional | PDF ↗ |
| K860044 | CALCIUM (CPC) REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-11 | Traditional | PDF ↗ |
| K855041 | CALCIUM LIQUID STABLE REAGENT SET | Medical Analysis Systems, Inc. | 1986-01-22 | Traditional | PDF ↗ |
| K854716 | NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 | Nobel Scientific Industries, Inc. | 1986-01-07 | Traditional | PDF ↗ |
| K853050 | CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ | Simmler, Inc. | 1985-08-02 | Traditional | PDF ↗ |
| K852657 | AMRESCO CALCIUM REAGENT SET | American Research Products Co. | 1985-07-15 | Traditional | PDF ↗ |
| K852002 | CA BUFFER CA DYE | Alpkem Corp. | 1985-06-25 | Traditional | PDF ↗ |
| K850929 | CALCIUM | Dilab, Inc. | 1985-06-10 | Traditional | PDF ↗ |
| K850281 | CALCIUM | Boehringer Mannheim Corp. | 1985-02-06 | Traditional | PDF ↗ |
| K844241 | CALCIUM REAGENT FOR DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | 1985-01-03 | Traditional | PDF ↗ |
| K844243 | TOTAL BILIRUBIN FOR DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | 1985-01-03 | Traditional | PDF ↗ |
| K843895 | TOTAL CALCIUM REAGENT SET | Livonia Diagnostics, Inc. | 1984-10-30 | Traditional | PDF ↗ |
| K843353 | RAICHEM CALCIUM REAGENT | Reagents Applications, Inc. | 1984-09-20 | Traditional | PDF ↗ |
| K843152 | SYSTEMATE CALCIUM 67214 | Em Diagnostic Systems, Inc. | 1984-08-29 | Traditional | PDF ↗ |
| K842509 | CALCIUM ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-07-20 | Traditional | PDF ↗ |
| K841051 | SERUM CALCIUM REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K834336 | FLOW-PAC CALCIUM REAGENT SET | American Research Products Co. | 1984-02-21 | Traditional | PDF ↗ |
| K833035 | CALCIUM DYE REAGENT-CS-718-A/BUFFER | Fisher Scientific Co., LLC | 1983-11-03 | Traditional | PDF ↗ |
| K832708 | PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS | American Dade | 1983-10-14 | Traditional | PDF ↗ |
| K832183 | SANDARE CALCIUM PROCEDURE | Sandare Chemical Co., Inc. | 1983-08-24 | Traditional | PDF ↗ |
| K830238 | ULTRA CHEM CRESOLCAVERSACHEM #65082 | Emd Chemicals, Inc. | 1983-02-18 | Traditional | PDF ↗ |
| K823756 | ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 | Em Industries, Inc. | 1983-01-12 | Traditional | PDF ↗ |
| K823577 | COBAS REAGENT FOR CALCIUM | Hoffmann-La Roche, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K823219 | LIQUIZYME CALCIUM REAGENT SET | American Research Products Co. | 1982-12-03 | Traditional | PDF ↗ |
| K822469 | PSI CALCIUM REAGENT | Pointe Scientific, Inc., | 1982-09-14 | Traditional | PDF ↗ |
| K821196 | SERUM CALCIUM REAGENT SET | Omega Medical Electronics | 1982-07-13 | Traditional | PDF ↗ |
| K820241 | WAKO CALCIUM C TEST | Wako Chemicals USA, Inc. | 1982-02-12 | Traditional | PDF ↗ |
| K820090 | ASTRA-T CALCIUM REAGENT | Hi Chem, Inc. | 1982-01-28 | Traditional | PDF ↗ |
| K812835 | TOTAL CALCIUM REAGENT SET | Anco Medical Reagents & Assoc. | 1981-10-09 | Traditional | PDF ↗ |
| K812110 | GILCHEM CALCIUM REAGENT | Gilford Diagnostics | 1981-08-13 | Traditional | PDF ↗ |
| K811748 | KING DIAGNOSTICS CALCIUM TEST | King Diagnostics, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K802923 | BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY | Beckman Instruments, Inc. | 1980-12-19 | Traditional | PDF ↗ |
| K802164 | 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. | Panmed, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K800680 | REAGENTS FOR DETERM. CALCIUM IN HUMAN | Diagnostic Solutions, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K792337 | DONNECT. DIAG. CALCIUM DIAG. REAGENT | Connecticut Diagnostics, Ltd. | 1979-12-06 | Traditional | PDF ↗ |
| K780983 | CALCIUM REAGENT SYSTEM NO. 585 | Sigma Chemical Co. | 1978-07-27 | Traditional | PDF ↗ |
| K771831 | CALCIUM | Gamma Enterprises, Inc. | 1977-10-25 | Traditional | PDF ↗ |
| K771310 | CALCIUM REAGENT | Mallinckrodt Critical Care | 1977-08-03 | Traditional | PDF ↗ |
| K770460 | CENTRIFI CHEM CALCIUM REAGENT | Union Carbide Corp. | 1977-06-02 | Traditional | PDF ↗ |
| K770449 | CALCIUM PROCEDURE, TEKPOINT DIRECT | Icn Pharmaceuticals, Inc. | 1977-05-03 | Traditional | PDF ↗ |
| K760468 | TEST, REFORMULATED HYCEL HMA CALCIUM | Hycel, Inc. | 1976-11-01 | Traditional | PDF ↗ |
| K760475 | REAGENT, CALCIUM DETERMINATION | Simmler & Son, Inc. | 1976-10-29 | Traditional | PDF ↗ |
Product code CIC · Class II · Clinical Chemistry. Data: openFDA.