ABL835 FLEX ANALYZER WITH PLEURAL PH
FDA 510(k) clearance K110416 · decided 2011-03-24
Clearance details
- K-number
- K110416
- Device name
- ABL835 FLEX ANALYZER WITH PLEURAL PH
- Applicant
- Radiometer Medical Aps
- Decision
- Substantially Equivalent
- Date received
- 2011-02-14
- Decision date
- 2011-03-24
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Broenshoej, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the recall (Z-2162-2012) | Radiometer America Inc | 2012-08-08 |
| The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intend recall (Z-2163-2012) | Radiometer America Inc | 2012-08-08 |