DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL— 510(k) K113373
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K113373 for DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL, Substantially Equivalent on 2011-12-30. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Newark, DE, US
Recent devices under product code JIT
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