Cleared Traditional

RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3

K130236 · Radiometer Medical Aps · Chemistry
Mar 2013
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K130236 is an FDA 510(k) clearance for the RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3, 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 March 15, 2013, 44 days after receiving the submission on January 30, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K130236 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2013
Decision Date March 15, 2013
Days to Decision 44 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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