ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
FDA 510(k) clearance K103548 · decided 2011-06-02
Clearance details
- K-number
- K103548
- Device name
- ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-12-03
- Decision date
- 2011-06-02
- Days to decision
- 181 days
- Clearance type
- Abbreviated
- Product code
- JIT
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- East Walpole, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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