RANDOX PREALBUMIN— 510(k) K000661

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K000661 for RANDOX PREALBUMIN, Substantially Equivalent on 2000-04-13. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JZJ
Device class: Class 1
Regulation: 21 CFR 866.5060
Advisory panel: Immunology
Date received: 2000-02-28
Decision date: 2000-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, Co. Antrim, IE

Download summary PDF View on FDA.gov ↗

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