ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
FDA 510(k) clearance K110530 · decided 2012-04-30
Clearance details
- K-number
- K110530
- Device name
- ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
- Applicant
- HORIBA ABX SAS
- Decision
- Substantially Equivalent
- Date received
- 2011-02-24
- Decision date
- 2012-04-30
- Days to decision
- 431 days
- Clearance type
- Abbreviated
- 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 |
|---|---|---|
| a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry recall (Z-1586-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |
| ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC recall (Z-1146-2014) | Horiba Instruments, Inc dba Horiba Medical | 2014-03-05 |
| ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and Hig recall (Z-0924-2014) | Horiba Instruments, Inc dba Horiba Medical | 2014-02-03 |