DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)— 510(k) K083339
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K083339 for DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS), Substantially Equivalent on 2009-03-09. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code CIC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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