Cleared Traditional

AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL

K071580 · Thermofisher Scientific OY · Chemistry
Oct 2007
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K071580 is an FDA 510(k) clearance for the AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Thermofisher Scientific OY (Vantaa, FI). The FDA issued a Cleared decision on October 3, 2007, 117 days after receiving the submission on June 8, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K071580 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2007
Decision Date October 03, 2007
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIT — Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1100

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