DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
FDA 510(k) clearance K103360 · decided 2010-12-17
Clearance details
- K-number
- K103360
- Device name
- DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
- Applicant
- Siemens Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-16
- Decision date
- 2010-12-17
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- JIT
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.