ABL8X7 FLEX
FDA 510(k) clearance K051968 · decided 2006-10-16
Clearance details
- K-number
- K051968
- Device name
- ABL8X7 FLEX
- Applicant
- Radiometer Medical Aps
- Decision
- Substantially Equivalent
- Date received
- 2005-07-20
- Decision date
- 2006-10-16
- Days to decision
- 453 days
- Clearance type
- Traditional
- Product code
- CGL
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bronshoj, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyz recall (Z-1293-2015) | Radiometer America Inc | 2015-03-18 |
| S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark recall (Z-1008-2012) | Radiometer America Inc | 2012-02-13 |
| Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on A recall (Z-1015-2010) | Radiometer America Inc | 2010-03-05 |