Cleared Traditional

Randox RX Daytona Plus Alkaline Phosphatase (ALP)

K162275 · Randox Laboratories Limited · Chemistry
Apr 2017
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K162275 is an FDA 510(k) clearance for the Randox RX Daytona Plus Alkaline Phosphatase (ALP), a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on April 21, 2017, 252 days after receiving the submission on August 12, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K162275 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2016
Decision Date April 21, 2017
Days to Decision 252 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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