TINA-QUANT FERRITIN GEN. 4— 510(k) K100538

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K100538 for TINA-QUANT FERRITIN GEN. 4, Substantially Equivalent on 2010-06-22. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code DBF
Advisory panel: Immunology
Date received: 2010-02-25
Decision date: 2010-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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