Cleared Traditional

HIGH METABOLITE QUALICHECK

K130415 · Radiometer Medical Aps · Chemistry
Mar 2013
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K130415 is an FDA 510(k) clearance for the HIGH METABOLITE QUALICHECK, a Controls For Blood-gases, (assayed And Unassayed) (Class I — General Controls, product code JJS), submitted by Radiometer Medical Aps (Broenshoej, DK). The FDA issued a Cleared decision on March 26, 2013, 35 days after receiving the submission on February 19, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K130415 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2013
Decision Date March 26, 2013
Days to Decision 35 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

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