K000489

Substantially Equivalent

ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST

Applicant: Helix Diagnostics, Inc.
Product code: LLL
Advisory panel: Immunology
Date received: 2000-02-14
Decision date: 2000-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

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