ABL90 FLEX
FDA 510(k) clearance K130144 · decided 2013-07-31
Clearance details
- K-number
- K130144
- Device name
- ABL90 FLEX
- Applicant
- Radiometer Medical Aps
- Decision
- Substantially Equivalent
- Date received
- 2013-01-22
- Decision date
- 2013-07-31
- Days to decision
- 190 days
- Clearance type
- Special
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- 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 |
|---|---|---|
| AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let recall (Z-1582-2018) | Radiometer Medical ApS | 2018-03-14 |
| AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Cata recall (Z-0899-2017) | Radiometer America Inc | 2016-12-22 |
| AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay an recall (Z-0748-2016) | Radiometer America Inc | 2016-02-03 |