510(k) K002609— TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM

Substantially Equivalent

Roche Diagnostics Corp.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DHR
Advisory panel: Immunology
Date received: 2000-08-22
Decision date: 2000-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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