Hematocrit and Metabolite QUALICHECK— 510(k) K150226

Name: FDA 510(k) clearance K150226
Creator: U.S. Food and Drug Administration
Published: 2015-05-13

Substantially Equivalent

Radiometer Medical Aps

FDA 510(k) clearance K150226 for Hematocrit and Metabolite QUALICHECK, Substantially Equivalent on 2015-05-13. Applicant: Radiometer Medical Aps. Device class: 1.

Clearance details

Applicant: Radiometer Medical Aps
Product code: Code JJS
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2015-02-02
Decision date: 2015-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bronshoj, DK

Download summary PDF View on FDA.gov ↗

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K033063 — MISSION CONTROLS2003-12-12
K022525 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 5092002-08-15

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