Cleared Traditional

UREA/BUN, SCAL, NORTROL, ABTROL

K073295 · Thermofisher Scientific OY · Chemistry
May 2008
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K073295 is an FDA 510(k) clearance for the UREA/BUN, SCAL, NORTROL, ABTROL, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Thermofisher Scientific OY (Vantaa, FI). The FDA issued a Cleared decision on May 29, 2008, 188 days after receiving the submission on November 23, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K073295 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2007
Decision Date May 29, 2008
Days to Decision 188 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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