PRESTIGE 24I; BIOLIS 24I; MGC 240— 510(k) K103531

Substantially Equivalent

Tokyo Boeki Medisys, Inc.

FDA 510(k) clearance K103531 for PRESTIGE 24I; BIOLIS 24I; MGC 240, Substantially Equivalent on 2011-12-01. Applicant: Tokyo Boeki Medisys, Inc..

Clearance details

Applicant: Tokyo Boeki Medisys, Inc.
Product code: Code CFR
Advisory panel: Clinical Chemistry
Date received: 2010-12-01
Decision date: 2011-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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