ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2— 510(k) K040431

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K040431 for ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2, Substantially Equivalent on 2004-03-10. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DAO
Advisory panel: Immunology
Date received: 2004-02-19
Decision date: 2004-03-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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