K990915

Substantially Equivalent

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY

Applicant: Stellar Bio Systems, Inc.
Product code: DHN
Advisory panel: Immunology
Date received: 1999-03-18
Decision date: 1999-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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