TINA-QUANT IGG GEN.2— 510(k) K050113

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K050113 for TINA-QUANT IGG GEN.2, Substantially Equivalent on 2005-02-08. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DEW
Advisory panel: Immunology
Date received: 2005-01-18
Decision date: 2005-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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