CHOLINESTERASE GEN.2 TEST SYSTEM— 510(k) K061093

Name: FDA 510(k) clearance K061093
Creator: U.S. Food and Drug Administration
Published: 2006-07-03

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K061093 for CHOLINESTERASE GEN.2 TEST SYSTEM, Substantially Equivalent on 2006-07-03. Applicant: Roche Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DIH
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 2006-04-19
Decision date: 2006-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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