TINA-QUANT TRANSFERRIN VER.2— 510(k) K012371

Name: FDA 510(k) clearance K012371
Creator: U.S. Food and Drug Administration
Published: 2001-09-19

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K012371 for TINA-QUANT TRANSFERRIN VER.2, Substantially Equivalent on 2001-09-19. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DDG
Device class: Class 2
Regulation: 21 CFR 866.5880
Advisory panel: Immunology
Date received: 2001-07-26
Decision date: 2001-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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