TINA-QUANT ALBUMIN GEN.2— 510(k) K113072

Name: FDA 510(k) clearance K113072
Creator: U.S. Food and Drug Administration
Published: 2012-05-14

Substantially Equivalent

Roche Diagnostics Operations

FDA 510(k) clearance K113072 for TINA-QUANT ALBUMIN GEN.2, Substantially Equivalent on 2012-05-14. Applicant: Roche Diagnostics Operations. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Operations
Product code: Code DCF
Device class: Class 2
Regulation: 21 CFR 866.5040
Advisory panel: Immunology
Date received: 2011-10-17
Decision date: 2012-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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