ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
FDA 510(k) clearance K082638 · decided 2009-02-26
Clearance details
- K-number
- K082638
- Device name
- ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-10
- Decision date
- 2009-02-26
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- KLI
- Device class
- 2
- Regulation number
- 862.1700
- 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.
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