K843826

Substantially Equivalent

COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL

Applicant: Roche Diagnostic Systems, Inc.
Product code: LGS
Advisory panel: Clinical Toxicology
Date received: 1984-09-28
Decision date: 1985-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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