ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT— 510(k) K954700

Substantially Equivalent

Helix Diagnostics, Inc.

FDA 510(k) clearance K954700 for ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT, Substantially Equivalent on 1995-12-15. Applicant: Helix Diagnostics, Inc..

Clearance details

Applicant: Helix Diagnostics, Inc.
Product code: 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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