ABL90 FLEX SERIES
FDA 510(k) clearance K092686 · decided 2010-08-06
Clearance details
- K-number
- K092686
- Device name
- ABL90 FLEX SERIES
- Applicant
- Radiometer Medical Aps
- Decision
- Substantially Equivalent
- Date received
- 2009-09-02
- Decision date
- 2010-08-06
- Days to decision
- 338 days
- Clearance type
- Traditional
- Product code
- CEM
- Device class
- 2
- Regulation number
- 862.1600
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bronshoj, DK
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Radiometer Medical Aps
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (K253491) | Roche Diagnostics | 2026-02-12 |
| ABL90 FLEX PLUS System (K241037) | Radiometer Medicals Aps | 2025-01-14 |
| EasyStat 300 (K220396) | Medica Corporation | 2023-09-26 |
| ISE Electrodes (K230890) | Randox Laboratories, Ltd. | 2023-09-08 |
| SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ (K200544) | Diamond Diagnostics, Inc. | 2020-10-01 |
| FLEXLAB 3.6, ACCELERATOR A3600 (K121012) | Inpeco S.P.A. | 2012-08-31 |
| 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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Seri recall (Z-1659-2025) | Radiometer Medical ApS | 2025-04-23 |
| ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 recall (Z-2320-2019) | Radiometer America Inc | 2019-08-22 |
| ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automa recall (Z-0816-2014) | Radiometer America Inc | 2014-01-23 |
| ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All recall (Z-2112-2011) | Radiometer America Inc | 2011-04-28 |
| ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained technologists, recall (Z-1011-2011) | Radiometer America Inc | 2011-02-02 |