TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)— 510(k) K042485

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K042485 for TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE), Substantially Equivalent on 2004-10-29. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code NQD
Advisory panel: Immunology
Date received: 2004-09-13
Decision date: 2004-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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