K170293

Substantially Equivalent

Emit II Plus Cocaine Metabolite Assay

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: DIO
Advisory panel: Clinical Toxicology
Date received: 2017-01-31
Decision date: 2017-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.