ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
FDA 510(k) clearance K002290 · decided 2000-09-13
Clearance details
- K-number
- K002290
- Device name
- ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
- Applicant
- Radiometer Medical A/S
- Decision
- Substantially Equivalent
- Date received
- 2000-07-27
- Decision date
- 2000-09-13
- Days to decision
- 48 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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