THE HELENA V8 IMMUNODISPLACEMENT KIT— 510(k) K111369

Substantially Equivalent

Helena Laboratories Uk, Ltd.

FDA 510(k) clearance K111369 for THE HELENA V8 IMMUNODISPLACEMENT KIT, Substantially Equivalent on 2012-06-26. Applicant: Helena Laboratories Uk, Ltd..

Clearance details

Applicant: Helena Laboratories Uk, Ltd.
Product code: Code CFF
Advisory panel: Immunology
Date received: 2011-05-16
Decision date: 2012-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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