FDA Product Code
FDA Product Code CJY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1145
510(k) Clearances — 47 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K244042 | Calcium2 | Abbott Ireland | 2025-02-10 | Traditional | PDF ↗ |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | HORIBA ABX SAS | 2019-07-26 | Traditional | PDF ↗ |
| K182042 | Randox Calcium (Ca) | Randox Laboratories, Ltd. | 2018-10-23 | Traditional | PDF ↗ |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZO | Elitechgroup | 2015-07-22 | Traditional | PDF ↗ |
| K123171 | ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT | HORIBA ABX SAS | 2013-07-03 | Abbreviated | PDF ↗ |
| K120626 | EON CALCIUM REGENT | Vital Diagnostics (Manufacturing) Ptyltd | 2012-08-22 | Traditional | PDF ↗ |
| K083386 | ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) | Siemens Healthcare Diagnostics | 2009-04-02 | Traditional | PDF ↗ |
| K072356 | S-TEST CA | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 | Traditional | PDF ↗ |
| K073355 | CALCIUM, SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | 2008-02-28 | Traditional | PDF ↗ |
| K072443 | VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY | Ortho-Clinical Diagnostics, Inc. | 2007-09-24 | Special | PDF ↗ |
| K072440 | VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) | Ortho-Clinical Diagnostics, Inc. | 2007-09-20 | Special | PDF ↗ |
| K062855 | CALCIUM | Abbott Laboratories | 2006-11-22 | Traditional | PDF ↗ |
| K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | Olympus America, Inc. | 2006-10-05 | Traditional | PDF ↗ |
| K051757 | CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 | Diagnostic Chemicals , Ltd. | 2005-11-10 | Traditional | PDF ↗ |
| K040972 | CALCIUM, AZO DYE REAGENT | Genchem, Inc. | 2004-12-27 | Traditional | PDF ↗ |
| K021334 | WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5 | Wiener Laboratories Saic | 2002-09-10 | Traditional | PDF ↗ |
| K022049 | MODIFICATION TO RAICHEM CALCIUM REAGENT | Hemagen Diagnostics, Inc. | 2002-07-19 | Special | PDF ↗ |
| K011441 | JAS CALCIUM (ARSENAZO) REAGENT | Jas Diagnostics, Inc. | 2001-07-09 | Traditional | PDF ↗ |
| K983789 | CARESIDE CALCIUM, ORIGINAL | Careside, Inc. | 1998-12-17 | Traditional | PDF ↗ |
| K981794 | HICHEM CALCIUM REAGENT KIT | Hichem Diagnostics | 1998-07-29 | Traditional | PDF ↗ |
| K982035 | OLYMPUS CALCIUM ARSENAZO III REAGENT | Olympus Diagnostica GmbH | 1998-06-24 | Traditional | PDF ↗ |
| K981578 | CA | Abbott Laboratories | 1998-06-16 | Traditional | PDF ↗ |
| K981232 | CA | Abbott Mfg., Inc. | 1998-05-18 | Traditional | PDF ↗ |
| K974607 | RANDOX CALCIUM | Randox Laboratories, Ltd. | 1998-02-02 | Traditional | PDF ↗ |
| K963536 | SIGMA DIAGNOSTICS CALICIUM REAGENT | Sigma Diagnostics, Inc. | 1996-10-10 | Traditional | PDF ↗ |
| K961226 | EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-07 | Traditional | PDF ↗ |
| K953395 | SYNERMED CALCIUM REAGENT KIT | Synermed, Inc. | 1995-08-31 | Traditional | PDF ↗ |
| K944255 | DMA CALCIUM PLUS PROCEDURE | Data Medical Associates, Inc. | 1994-12-06 | Traditional | PDF ↗ |
| K941764 | HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 | Hi Chem, Inc. | 1994-05-13 | Traditional | PDF ↗ |
| K933678 | SIGMA CALCIUM REAGENT | Sigma Chemical Co. | 1994-03-11 | Traditional | PDF ↗ |
| K922835 | CALCIUM (AZ III) REAGENT | King Diagnostics, Inc. | 1992-08-04 | Traditional | PDF ↗ |
| K902476 | CALCIUM:ARSENAZO III | Amresco, Inc. | 1990-07-17 | Traditional | PDF ↗ |
| K900231 | COULTER CALCIUM REAGENT | Coulter Corp. | 1990-04-03 | Traditional | PDF ↗ |
| K895873 | CALCIUM, CATALOGUE NUMBER140-20 | Diagnostic Chemicals, Ltd. (Usa) | 1989-12-12 | Traditional | PDF ↗ |
| K894476 | CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION | Catachem, Inc. | 1989-10-12 | Traditional | PDF ↗ |
| K894204 | CALCIUM (ARSENAZO III) REAGENT | Sigma Diagnostics, Inc. | 1989-10-04 | Traditional | PDF ↗ |
| K891061 | BIOTROL CALCIUM MONOREACTIF | Biotrol, USA, Inc. | 1989-08-10 | Traditional | PDF ↗ |
| K890584 | HI CHEM CALCIUM REAGENT #88808 | Hichem Diagnostics | 1989-04-10 | Traditional | PDF ↗ |
| K890302 | CALCIUM PLUS PROCEDURE | Data Medical Associates, Inc. | 1989-02-27 | Traditional | PDF ↗ |
| K883453 | ROCHE REAGENT FOR CALCIUM | Roche Diagnostic Systems, Inc. | 1988-10-25 | Traditional | PDF ↗ |
| K880576 | RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID) | Reagents Applications, Inc. | 1988-06-10 | Traditional | PDF ↗ |
| K880949 | SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | 1988-04-05 | Traditional | PDF ↗ |
| K880242 | KONE CALCIUM TEST | The Rupp & Bowman Co. | 1988-03-15 | Traditional | PDF ↗ |
| K813040 | ULTRACHEM CA, ITEM #64975 | Harleco | 1981-11-10 | Traditional | PDF ↗ |
| K771928 | CALCIUM SET, ITEM NO. 65004 | Harleco | 1977-11-14 | Traditional | PDF ↗ |
| K770817 | ULTRACHEM CALCIUM | Harleco | 1977-07-11 | Traditional | PDF ↗ |
| K761029 | AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL | Harleco | 1976-11-30 | Traditional | PDF ↗ |
Product code CJY · Class II · Clinical Chemistry. Data: openFDA.