510(k) K960091— ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT

Substantially Equivalent

Helix Diagnostics, Inc.

Clearance details

Applicant: Helix Diagnostics, Inc.
Product code: Code LRM
Advisory panel: Immunology
Date received: 1996-01-11
Decision date: 1996-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

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