Cleared Traditional

ORION DIAGNOSTICA UNIQ PINP RIA

K043125 · Orion Diagnostica, OY · Chemistry
May 2005
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K043125 is an FDA 510(k) clearance for the ORION DIAGNOSTICA UNIQ PINP RIA, a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II — Special Controls, product code CIN), submitted by Orion Diagnostica, OY (Espoo, FI). The FDA issued a Cleared decision on May 4, 2005, 173 days after receiving the submission on November 12, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K043125 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2004
Decision Date May 04, 2005
Days to Decision 173 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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