RHIGENE ANA ELISA TEST SYSTEM— 510(k) K994071

Substantially Equivalent

Rhigene, Inc.

FDA 510(k) clearance K994071 for RHIGENE ANA ELISA TEST SYSTEM, Substantially Equivalent on 2000-01-18. Applicant: Rhigene, Inc..

Clearance details

Applicant: Rhigene, Inc.
Product code: Code LJM
Advisory panel: Immunology
Date received: 1999-12-02
Decision date: 2000-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

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