IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM— 510(k) K091361
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K091361 for IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM, Substantially Equivalent on 2009-12-16. Applicant: Siemens Healthcare Diagnostics.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code LIP
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suwanee, GA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.