ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II— 510(k) K122858

Name: FDA 510(k) clearance K122858
Creator: U.S. Food and Drug Administration
Published: 2012-10-03

Substantially Equivalent

Elitechgroup

FDA 510(k) clearance K122858 for ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II, Substantially Equivalent on 2012-10-03. Applicant: Elitechgroup. Device class: 2.

Clearance details

Applicant: Elitechgroup
Product code: Code JFJ
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 2012-09-18
Decision date: 2012-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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