ABL80 FLEX ANALYZER
FDA 510(k) clearance K051804 · decided 2005-11-01
Clearance details
- K-number
- K051804
- Device name
- ABL80 FLEX ANALYZER
- Applicant
- Sendx Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-05
- Decision date
- 2005-11-01
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas recall (Z-2304-2012) | Sendx Medical Inc | 2012-08-30 |
| SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FL recall (Z-1384-2012) | Sendx Medical Inc | 2012-04-09 |
| ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863 recall (Z-1201-2007) | Sendx Medical Inc | 2007-08-29 |