510(k) K913041— ANTI-DSDNA ANTIBODY TEST

Substantially Equivalent

Helix Diagnostics, Inc.

Clearance details

Applicant: Helix Diagnostics, Inc.
Product code: Code LLL
Advisory panel: Immunology
Date received: 1991-07-09
Decision date: 1991-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

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