EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR— 510(k) K083487
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K083487 for EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR, Substantially Equivalent on 2009-03-30. Applicant: Siemens Healthcare Diagnostics.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code NRP
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.