ADVIA CHEMISTRY GLUH_3 REAGENTS— 510(k) K120681
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K120681 for ADVIA CHEMISTRY GLUH_3 REAGENTS, Substantially Equivalent on 2012-05-15. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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More clearances from Siemens Healthcare Diagnostics, Inc.
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