TINA-QUANT APOLIPOPROTEIN A-1 VER.2— 510(k) K013278

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K013278 for TINA-QUANT APOLIPOPROTEIN A-1 VER.2, Substantially Equivalent on 2001-11-15. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DEL
Advisory panel: Immunology
Date received: 2001-10-01
Decision date: 2001-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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