Cleared Traditional

Hematocrit and Metabolite QUALICHECK

K150226 · Radiometer Medical Aps · Chemistry
May 2015
Decision
100d
Days
Class 1
Risk

About This 510(k) Submission

K150226 is an FDA 510(k) clearance for the Hematocrit and Metabolite QUALICHECK, a Controls For Blood-gases, (assayed And Unassayed) (Class I — General Controls, product code JJS), submitted by Radiometer Medical Aps (Bronshoj, DK). The FDA issued a Cleared decision on May 13, 2015, 100 days after receiving the submission on February 2, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K150226 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2015
Decision Date May 13, 2015
Days to Decision 100 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
CueSee Hypoxic
K152553 · Eurotrol B.V. · Apr 2016
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