ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II— 510(k) K153644

Name: FDA 510(k) clearance K153644
Creator: U.S. Food and Drug Administration
Published: 2016-09-07

Substantially Equivalent

Elitechgroup

FDA 510(k) clearance K153644 for ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II, Substantially Equivalent on 2016-09-07. Applicant: Elitechgroup. Device class: 2.

Clearance details

Applicant: Elitechgroup
Product code: Code CFR
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2015-12-21
Decision date: 2016-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sees, FR

Download summary PDF View on FDA.gov ↗

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