ALKALINE PHOSPHATASE KIT— 510(k) K923507

Name: FDA 510(k) clearance K923507
Creator: U.S. Food and Drug Administration
Published: 1992-12-03

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K923507 for ALKALINE PHOSPHATASE KIT, Substantially Equivalent on 1992-12-03. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1992-07-15
Decision date: 1992-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antrim, N. Ireland, IR

Download summary PDF View on FDA.gov ↗

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