BIOLIS 12I— 510(k) K110520

Substantially Equivalent

Tokyo Boeki Medisys, Inc.

FDA 510(k) clearance K110520 for BIOLIS 12I, Substantially Equivalent on 2012-03-23. Applicant: Tokyo Boeki Medisys, Inc.. Device class: 2.

Clearance details

Applicant: Tokyo Boeki Medisys, Inc.
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 2011-02-23
Decision date: 2012-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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