K954700

Substantially Equivalent

ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT

Applicant: Helix Diagnostics, Inc.
Product code: LKJ
Advisory panel: Immunology
Date received: 1995-10-12
Decision date: 1995-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

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