DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)— 510(k) K130698
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K130698 for DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL), Substantially Equivalent on 2013-04-05. Applicant: Siemens Healthcare Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- 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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.