K102779

Substantially Equivalent

EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: DJG
Advisory panel: Clinical Toxicology
Date received: 2010-09-24
Decision date: 2011-03-18
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.