ABL90 FLEX PLUS System
FDA 510(k) clearance K241037 · decided 2025-01-14
Clearance details
- K-number
- K241037
- Device name
- ABL90 FLEX PLUS System
- Applicant
- Radiometer Medicals Aps
- Decision
- Substantially Equivalent
- Date received
- 2024-04-16
- Decision date
- 2025-01-14
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- CEM
- Device class
- 2
- Regulation number
- 862.1600
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Brønshøj, DK
- Third-party review
- No
- Expedited review
- No
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| SMARTLYTE ELECTROLYTE ANALYZER (K121040) | Diamond Diagnostics, Inc. | 2012-08-30 |
| GEM PREMIER 4000 (K112995) | Instrumentation Laboratory CO | 2012-05-03 |
| BIOLIS 12I (K110520) | Tokyo Boeki Medisys, Inc. | 2012-03-23 |
| AU5800(R) CHEMISTRY ANALYZER (K112412) | Beckman Coulter, Inc. | 2011-12-23 |
| POLY-CHEM 90 ISE MODULE (K112408) | Polymedco, Inc. | 2011-11-04 |
| EASTLYTE NA/K/CA/PH (K112788) | Medica Corp. | 2011-10-20 |
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Recalls involving this device
No recalls on record reference this clearance.