RANDOX HAEMOGLOBIN A1C— 510(k) K021897

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K021897 for RANDOX HAEMOGLOBIN A1C, Substantially Equivalent on 2002-11-26. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2002-06-10
Decision date: 2002-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, IE

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