RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT— 510(k) K972220

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K972220 for RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT, Substantially Equivalent on 1997-09-09. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DHR
Advisory panel: Immunology
Date received: 1997-06-12
Decision date: 1997-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, Co. Antrim, IE

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