FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
K Number: K123171
·
Decision Jul 3, 2013
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
46
Applicant Total
17
Review Days
267
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
- K Number
- K123171
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HORIBA ABX SAS
- Date Received
- October 9, 2012
- Decision Date
- July 3, 2013
- Product Code
- CJY
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CJY | Azo Dye, Calcium | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CJY), ordered by most recent decision date.
Calcium2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Randox Calcium (Ca)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELITech Clinical Systems CALCIUM ARSENAZO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EON CALCIUM REGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by HORIBA ABX SAS
| K Number | Device Name | ||
|---|---|---|---|
| K232946 | Yumizen H2500 | May 21, 2024 | Substantially Equivalent |
| K193649 | Yumizen C1200 Creatinine PAP | May 10, 2021 | Substantially Equivalent |
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | Jun 26, 2020 | Substantially Equivalent |
| K192028 | Yumizen C1200 CRP | Jun 25, 2020 | Substantially Equivalent |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor | Mar 6, 2020 | Substantially Equivalent |
| K191993 | Yumizen C1200 CRP | Oct 3, 2019 | Substantially Equivalent |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | Aug 30, 2019 | Substantially Equivalent |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | Jul 26, 2019 | Substantially Equivalent |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CT | Nov 1, 2017 | Substantially Equivalent |
| K151133 | PENTRA XLR | Dec 9, 2015 | Substantially Equivalent |