CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797— 510(k) K091216
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K091216 for CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797, Substantially Equivalent on 2009-10-09. Applicant: Siemens Healthcare Diagnostics.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code JIL
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norowood, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.