ABL800 FLEX
FDA 510(k) clearance K041874 · decided 2004-10-08
Clearance details
- K-number
- K041874
- Device name
- ABL800 FLEX
- Applicant
- Radiometer Medical Aps
- Decision
- Substantially Equivalent
- Date received
- 2004-07-12
- Decision date
- 2004-10-08
- Days to decision
- 88 days
- Clearance type
- Traditional
- 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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