FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
K Number: K081276
·
Decision Sep 12, 2008
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
144
Applicant Total
19
Review Days
130
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Basic Information
- Device Name
- ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
- K Number
- K081276
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Horiba Abx
- Date Received
- May 5, 2008
- Decision Date
- September 12, 2008
- Product Code
- CFR
- 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 |
|---|---|---|---|
| CFR | Hexokinase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Horiba Abx
| K Number | Device Name | ||
|---|---|---|---|
| K073309 | ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT | Oct 17, 2008 | Substantially Equivalent |
| K071779 | ABX PENTRA URINE CAL | Mar 5, 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 |