ABL90 FLEX
FDA 510(k) clearance K132691 · decided 2014-11-13
Clearance details
- K-number
- K132691
- Device name
- ABL90 FLEX
- Applicant
- Radiometer Medical Aps
- Decision
- Substantially Equivalent
- Date received
- 2013-08-28
- Decision date
- 2014-11-13
- Days to decision
- 442 days
- Clearance type
- Traditional
- Product code
- MQM
- Device class
- 1
- Regulation number
- 862.1113
- 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
No recalls on record reference this clearance.