RANDOX COMPLEMENT C4— 510(k) K000468

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K000468 for RANDOX COMPLEMENT C4, Substantially Equivalent on 2000-03-27. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DBI
Device class: Class 2
Regulation: 21 CFR 866.5240
Advisory panel: Immunology
Date received: 2000-02-11
Decision date: 2000-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antrim, N. Ireland, IR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.