Cleared Traditional

ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL

K073191 · Thermofisher Scientific OY · Chemistry
Feb 2008
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K073191 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Thermofisher Scientific OY (Vantaa, FI). The FDA issued a Cleared decision on February 28, 2008, 107 days after receiving the submission on November 13, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K073191 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2007
Decision Date February 28, 2008
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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