TINA-QUANT CRP (LATEX)— 510(k) K032336

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K032336 for TINA-QUANT CRP (LATEX), Substantially Equivalent on 2003-08-05. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2003-07-29
Decision date: 2003-08-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.