TINA-QUANT APOLIPOPROTEIN VER.2— 510(k) K013249

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K013249 for TINA-QUANT APOLIPOPROTEIN VER.2, Substantially Equivalent on 2001-11-16. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DER
Advisory panel: Immunology
Date received: 2001-09-28
Decision date: 2001-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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