Product code CJY— Clinical Chemistry
CA
- Classification name
- Azo Dye, Calcium
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Total cleared
- 47
- First cleared
- Most recent
Market context for product code CJY
FDA has cleared devices under product code CJY between 1976 and 2025, filed by 37 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- 2025
- 2019
- 2018
- 2015
- 2013
- 2012
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2002
- 2001
- 1998
Top applicants under product code CJY
Recent clearances under product code CJY
- K244042 — Calcium2
- K191396 — Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
- K182042 — Randox Calcium (Ca)
- K151113 — ELITech Clinical Systems CALCIUM ARSENAZO
- K123171 — ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
- K120626 — EON CALCIUM REGENT
- K083386 — ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
- K072356 — S-TEST CA
- K073355 — CALCIUM, SCAL, NORTROL, ABTROL
- K072443 — VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
- K072440 — VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)
- K062855 — CALCIUM
- K061575 — OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
- K051757 — CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91
- K040972 — CALCIUM, AZO DYE REAGENT
- 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
- K022049 — MODIFICATION TO RAICHEM CALCIUM REAGENT
- K011441 — JAS CALCIUM (ARSENAZO) REAGENT
- K983789 — CARESIDE CALCIUM, ORIGINAL
- K981794 — HICHEM CALCIUM REAGENT KIT
- K982035 — OLYMPUS CALCIUM ARSENAZO III REAGENT
- K981578 — CA
- K981232 — CA
- K974607 — RANDOX CALCIUM
- K963536 — SIGMA DIAGNOSTICS CALICIUM REAGENT
- K961226 — EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE
- K953395 — SYNERMED CALCIUM REAGENT KIT
- K944255 — DMA CALCIUM PLUS PROCEDURE
- K941764 — HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808
- K933678 — SIGMA CALCIUM REAGENT
- K922835 — CALCIUM (AZ III) REAGENT
- K902476 — CALCIUM:ARSENAZO III
- K900231 — COULTER CALCIUM REAGENT
- K895873 — CALCIUM, CATALOGUE NUMBER140-20
- K894476 — CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION
- K894204 — CALCIUM (ARSENAZO III) REAGENT
- K891061 — BIOTROL CALCIUM MONOREACTIF
- K890584 — HI CHEM CALCIUM REAGENT #88808
- K890302 — CALCIUM PLUS PROCEDURE
- K883453 — ROCHE REAGENT FOR CALCIUM
- K880576 — RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)
- K880949 — SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
- K880242 — KONE CALCIUM TEST
- K813040 — ULTRACHEM CA, ITEM #64975
- K771928 — CALCIUM SET, ITEM NO. 65004
- K770817 — ULTRACHEM CALCIUM
- K761029 — AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.