EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR

EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR is an FDA 510(k)-cleared medical device (K083487) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 2009. Regulation: 8.