RANDOX BILIRUBIN— 510(k) K973995

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K973995 for RANDOX BILIRUBIN, Substantially Equivalent on 1997-12-08. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code GIG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1997-10-21
Decision date: 1997-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, IE

Download summary PDF View on FDA.gov ↗

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