GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
FDA 510(k) clearance K060205 · decided 2006-07-21
Clearance details
- K-number
- K060205
- Device name
- GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
- Applicant
- Horiba Abx
- Decision
- Substantially Equivalent
- Date received
- 2006-01-26
- Decision date
- 2006-07-21
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- CJE
- Device class
- 2
- Regulation number
- 862.1050
- 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 Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium R recall (Z-2692-2014) | Horiba Instruments, Inc dba Horiba Medical | 2014-09-24 |