K981282

Substantially Equivalent

ELECSYS AFP

Applicant: Roche Diagnostics GmbH
Product code: LOJ
Advisory panel: Immunology
Date received: 1998-04-08
Decision date: 1998-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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