Randox RX Daytona Plus Alkaline Phosphatase (ALP)— 510(k) K162275

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K162275 for Randox RX Daytona Plus Alkaline Phosphatase (ALP), Substantially Equivalent on 2017-04-21. Applicant: Randox Laboratories Limited.

Clearance details

Applicant: Randox Laboratories Limited
Product code: Code CJE
Advisory panel: Clinical Chemistry
Date received: 2016-08-12
Decision date: 2017-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

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