K011164

Substantially Equivalent

MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229

Applicant: Syva Co., Dade Behring, Inc.
Product code: KXS
Advisory panel: Clinical Toxicology
Date received: 2001-04-16
Decision date: 2001-05-10
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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