ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET— 510(k) K103716

Name: FDA 510(k) clearance K103716
Creator: U.S. Food and Drug Administration
Published: 2011-05-12

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K103716 for ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET, Substantially Equivalent on 2011-05-12. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 2010-12-21
Decision date: 2011-05-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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