MESACUP MODELS BP180 AND BP230 ELISA KITS— 510(k) K071961

Name: FDA 510(k) clearance K071961
Creator: U.S. Food and Drug Administration
Published: 2008-08-25

Substantially Equivalent

Mbl International Corporation

FDA 510(k) clearance K071961 for MESACUP MODELS BP180 AND BP230 ELISA KITS, Substantially Equivalent on 2008-08-25. Applicant: Mbl International Corporation. Device class: 2.

Clearance details

Applicant: Mbl International Corporation
Product code: Code OEG
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2007-07-16
Decision date: 2008-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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