TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323— 510(k) K003064

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K003064 for TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323, Substantially Equivalent on 2001-05-01. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DDG
Advisory panel: Immunology
Date received: 2000-10-02
Decision date: 2001-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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