ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL— 510(k) K073191

Name: FDA 510(k) clearance K073191
Creator: U.S. Food and Drug Administration
Published: 2008-02-28

Substantially Equivalent

Thermofisher Scientific OY

FDA 510(k) clearance K073191 for ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL, Substantially Equivalent on 2008-02-28. Applicant: Thermofisher Scientific OY. Device class: 2.

Clearance details

Applicant: Thermofisher Scientific OY
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2007-11-13
Decision date: 2008-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vantaa, FI

Download summary PDF View on FDA.gov ↗

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