HOMOCYSTEINE TEST— 510(k) K113793

Substantially Equivalent

Roche

FDA 510(k) clearance K113793 for HOMOCYSTEINE TEST, Substantially Equivalent on 2012-06-05. Applicant: Roche.

Clearance details

Applicant: Roche
Product code: Code LPS
Advisory panel: Clinical Chemistry
Date received: 2011-12-23
Decision date: 2012-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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