Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator— 510(k) K151529
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K151529 for Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator, Substantially Equivalent on 2016-02-11. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- 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
- Newark, DE, US
Recent devices under product code CDZ
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view allRecalls naming K151529
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151529.
Data sourced from openFDA. This site is unofficial and independent of the FDA.