ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773— 510(k) K091867
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K091867 for ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773, Substantially Equivalent on 2010-01-14. Applicant: Siemens Healthcare Diagnostics. Device class: 1.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code CDZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1680
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.