RANDOX MYOGLOBIN— 510(k) K010700

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K010700 for RANDOX MYOGLOBIN, Substantially Equivalent on 2001-05-08. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DDR
Advisory panel: Immunology
Date received: 2001-03-08
Decision date: 2001-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, Co. Antrim, IE

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