ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
FDA 510(k) clearance K052007 · decided 2005-12-16
Clearance details
- K-number
- K052007
- Device name
- ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
- Applicant
- Horiba Abx
- Decision
- Substantially Equivalent
- Date received
- 2005-07-25
- Decision date
- 2005-12-16
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- CFR
- Device class
- 2
- Regulation number
- 862.1345
- 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 Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro recall (Z-0740-2016) | Horiba Instruments Inc | 2016-02-02 |
| ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 ( recall (Z-0902-2015) | Horiba Instruments, Inc dba Horiba Medical | 2015-01-02 |
| ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality c recall (Z-0904-2014) | Horiba Instruments, Inc dba Horiba Medical | 2014-01-31 |
| HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All recall (Z-1141-2013) | Horiba Instruments, Inc dba Horiba Medical | 2013-04-18 |