FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ABX PENTRA URINE CAL
K Number: K071779
·
Decision Mar 5, 2008
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
19
Review Days
247
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 URINE CAL
- K Number
- K071779
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Horiba Abx
- Date Received
- July 2, 2007
- Decision Date
- March 5, 2008
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIX), ordered by most recent decision date.
VITROS Chemistry Products Calibrator Kit 3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYSTEM CALIBRATER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Horiba Abx
| K Number | Device Name | ||
|---|---|---|---|
| K073309 | ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT | Oct 17, 2008 | Substantially Equivalent |
| K081276 | ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H | Sep 12, 2008 | Substantially Equivalent |
| K072115 | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H | Nov 30, 2007 | Substantially Equivalent |
| K070146 | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP | Oct 12, 2007 | Substantially Equivalent |
| K062737 | CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | Jun 12, 2007 | Substantially Equivalent |
| K060434 | ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL | Jun 5, 2007 | Substantially Equivalent |
| K070249 | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H | Apr 26, 2007 | Substantially Equivalent |
| K062180 | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP | Oct 2, 2006 | Substantially Equivalent |
| K061138 | ABX PENTRA 400 : CRP | Sep 29, 2006 | Substantially Equivalent |
| K060854 | ABX PENTRA 400: LIPOPROTEINS | Aug 24, 2006 | Substantially Equivalent |