ENZYME IMMUNOASSAY, VANCOMYCIN— 510(k) K060586

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K060586 for ENZYME IMMUNOASSAY, VANCOMYCIN, Substantially Equivalent on 2006-05-11. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LEH
Advisory panel: Clinical Toxicology
Date received: 2006-03-07
Decision date: 2006-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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