K020616

Substantially Equivalent

BAYER RAPIDPOINT 405 SYSTEM

Applicant: Bayer Diagnostics Corp.
Product code: GKR
Advisory panel: Hematology
Date received: 2002-02-25
Decision date: 2002-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

Download summary PDF View on FDA.gov ↗

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