Cleared Traditional

CueSee Hypoxic

K152553 · Eurotrol B.V. · Chemistry
Apr 2016
Decision
227d
Days
Class 1
Risk

About This 510(k) Submission

K152553 is an FDA 510(k) clearance for the CueSee Hypoxic, a Controls For Blood-gases, (assayed And Unassayed) (Class I — General Controls, product code JJS), submitted by Eurotrol B.V. (Ede, NL). The FDA issued a Cleared decision on April 22, 2016, 227 days after receiving the submission on September 8, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K152553 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2015
Decision Date April 22, 2016
Days to Decision 227 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJS — Controls For Blood-gases, (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

Similar Devices — JJS Controls For Blood-gases, (assayed And Unassayed)

All 66
Hematocrit and Metabolite QUALICHECK
K150226 · Radiometer Medical Aps · May 2015
HIGH METABOLITE QUALICHECK
K130415 · Radiometer Medical Aps · Mar 2013
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
K130236 · Radiometer Medical Aps · Mar 2013
MISSION CONTROLS
K033063 · Diamond Diagnostics, Inc. · Dec 2003
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
K022525 · Bio-Rad · Aug 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669
K022529 · Bio-Rad · Aug 2002