RANDOX CREATININE— 510(k) K973993

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K973993 for RANDOX CREATININE, Substantially Equivalent on 1998-03-06. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1997-10-21
Decision date: 1998-03-06
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.