K010984

Substantially Equivalent

EMIT 2000 GENTAMICIN PLUS ASSAY

Applicant: Syva Co., Dade Behring, Inc.
Product code: LCD
Advisory panel: Clinical Toxicology
Date received: 2001-04-02
Decision date: 2001-04-20
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.