Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
CJY — Predicate Candidate Screening
47 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
174 days90th percentile
47clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K244042 | Calcium2 | Abbott Ireland | 2025-02-10 | 42 | 0 |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | HORIBA ABX SAS | 2019-07-26 | 63 | 0 |
| K182042 | Randox Calcium (Ca) | Randox Laboratories, Ltd. | 2018-10-23 | 85 | 0 |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZO | Elitechgroup | 2015-07-22 | 86 | 0 |
| K123171 | ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX | HORIBA ABX SAS | 2013-07-03 | 267 | 0 |
| K120626 | EON CALCIUM REGENT | Vital Diagnostics (Manufacturing) Ptyltd | 2012-08-22 | 174 | 2 |
| K083386 | ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 | Siemens Healthcare Diagnostics | 2009-04-02 | 136 | 0 |
| K072356 | S-TEST CA | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 | 307 | 0 |
| K073355 | CALCIUM, SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | 2008-02-28 | 91 | 0 |
| K072443 | VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT | Ortho-Clinical Diagnostics, Inc. | 2007-09-24 | 25 | 1 |
| K072440 | VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALI | Ortho-Clinical Diagnostics, Inc. | 2007-09-20 | 21 | 3 |
| K062855 | CALCIUM | Abbott Laboratories | 2006-11-22 | 58 | 0 |
| K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR651 | Olympus America, Inc. | 2006-10-05 | 120 | 0 |
| K051757 | CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 | Diagnostic Chemicals , Ltd. | 2005-11-10 | 134 | 0 |
| K040972 | CALCIUM, AZO DYE REAGENT | Genchem, Inc. | 2004-12-27 | 257 | 0 |
| K021334 | WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. | Wiener Laboratories Saic | 2002-09-10 | 137 | 0 |
| K022049 | MODIFICATION TO RAICHEM CALCIUM REAGENT | Hemagen Diagnostics, Inc. | 2002-07-19 | 25 | 0 |
| K011441 | JAS CALCIUM (ARSENAZO) REAGENT | Jas Diagnostics, Inc. | 2001-07-09 | 60 | 0 |
| K983789 | CARESIDE CALCIUM, ORIGINAL | Careside, Inc. | 1998-12-17 | 51 | 0 |
| K981794 | HICHEM CALCIUM REAGENT KIT | Hichem Diagnostics | 1998-07-29 | 69 | 0 |
| K982035 | OLYMPUS CALCIUM ARSENAZO III REAGENT | Olympus Diagnostica GmbH | 1998-06-24 | 14 | 0 |
| K981578 | CA | Abbott Laboratories | 1998-06-16 | 43 | 0 |
| K981232 | CA | Abbott Mfg., Inc. | 1998-05-18 | 45 | 0 |
| K974607 | RANDOX CALCIUM | Randox Laboratories, Ltd. | 1998-02-02 | 54 | 0 |
| K963536 | SIGMA DIAGNOSTICS CALICIUM REAGENT | Sigma Diagnostics, Inc. | 1996-10-10 | 37 | 0 |
| K961226 | EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-07 | 39 | 1 |
| K953395 | SYNERMED CALCIUM REAGENT KIT | Synermed, Inc. | 1995-08-31 | 44 | 0 |
| K944255 | DMA CALCIUM PLUS PROCEDURE | Data Medical Associates, Inc. | 1994-12-06 | 96 | 0 |
| K941764 | HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 | Hi Chem, Inc. | 1994-05-13 | 45 | 0 |
| K933678 | SIGMA CALCIUM REAGENT | Sigma Chemical Co. | 1994-03-11 | 225 | 0 |
| K922835 | CALCIUM (AZ III) REAGENT | King Diagnostics, Inc. | 1992-08-04 | 53 | 0 |
| K902476 | CALCIUM:ARSENAZO III | Amresco, Inc. | 1990-07-17 | 42 | 0 |
| K900231 | COULTER CALCIUM REAGENT | Coulter Corp. | 1990-04-03 | 76 | 0 |
| K895873 | CALCIUM, CATALOGUE NUMBER140-20 | Diagnostic Chemicals, Ltd. (Usa) | 1989-12-12 | 69 | 0 |
| K894476 | CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION | Catachem, Inc. | 1989-10-12 | 86 | 0 |
| K894204 | CALCIUM (ARSENAZO III) REAGENT | Sigma Diagnostics, Inc. | 1989-10-04 | 107 | 0 |
| K891061 | BIOTROL CALCIUM MONOREACTIF | Biotrol, USA, Inc. | 1989-08-10 | 162 | 0 |
| K890584 | HI CHEM CALCIUM REAGENT #88808 | Hichem Diagnostics | 1989-04-10 | 63 | 0 |
| K890302 | CALCIUM PLUS PROCEDURE | Data Medical Associates, Inc. | 1989-02-27 | 35 | 0 |
| K883453 | ROCHE REAGENT FOR CALCIUM | Roche Diagnostic Systems, Inc. | 1988-10-25 | 74 | 0 |
| K880576 | RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID) | Reagents Applications, Inc. | 1988-06-10 | 121 | 0 |
| K880949 | SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | 1988-04-05 | 29 | 0 |
| K880242 | KONE CALCIUM TEST | The Rupp & Bowman Co. | 1988-03-15 | 55 | 0 |
| K813040 | ULTRACHEM CA, ITEM #64975 | Harleco | 1981-11-10 | 13 | 0 |
| K771928 | CALCIUM SET, ITEM NO. 65004 | Harleco | 1977-11-14 | 31 | 0 |
| K770817 | ULTRACHEM CALCIUM | Harleco | 1977-07-11 | 68 | 0 |
| K761029 | AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL | Harleco | 1976-11-30 | 18 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda