ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
FDA 510(k) clearance K072115 · decided 2007-11-30
Clearance details
- K-number
- K072115
- Device name
- ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
- Applicant
- Horiba Abx
- Decision
- Substantially Equivalent
- Date received
- 2007-08-01
- Decision date
- 2007-11-30
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- CGX
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Montpellier, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 20327 recall (Z-0289-2013) | Horiba Instruments, Inc dba Horiba Medical | 2012-11-14 |