OLYMPUS CALCIUM ARSENAZO III REAGENT
FDA 510(k) clearance K982035 · decided 1998-06-24
Clearance details
- K-number
- K982035
- Device name
- OLYMPUS CALCIUM ARSENAZO III REAGENT
- Applicant
- Olympus Diagnostica GmbH
- Decision
- Substantially Equivalent
- Date received
- 1998-06-10
- Decision date
- 1998-06-24
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- CJY
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Olympus Diagnostica GmbH
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API,
or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Calcium2 (K244042) | Abbott Ireland | 2025-02-10 |
| Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (K191396) | HORIBA ABX SAS | 2019-07-26 |
| Randox Calcium (Ca) (K182042) | Randox Laboratories, Ltd. | 2018-10-23 |
| ELITech Clinical Systems CALCIUM ARSENAZO (K151113) | Elitechgroup | 2015-07-22 |
| ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT (K123171) | HORIBA ABX SAS | 2013-07-03 |
| EON CALCIUM REGENT (K120626) | Vital Diagnostics (Manufacturing) Ptyltd | 2012-08-22 |
| ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) (K083386) | Siemens Healthcare Diagnostics | 2009-04-02 |
| S-TEST CA (K072356) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 |
| CALCIUM, SCAL, NORTROL, ABTROL (K073355) | Thermofisher Scientific OY | 2008-02-28 |
| VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY (K072443) | Ortho-Clinical Diagnostics, Inc. | 2007-09-24 |
| VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) (K072440) | Ortho-Clinical Diagnostics, Inc. | 2007-09-20 |
| CALCIUM (K062855) | Abbott Laboratories | 2006-11-22 |
Recalls involving this device
No recalls on record reference this clearance.