ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT— 510(k) K940588

Substantially Equivalent

Helix Diagnostics, Inc.

FDA 510(k) clearance K940588 for ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT, Substantially Equivalent on 1994-04-20. Applicant: Helix Diagnostics, Inc..

Clearance details

Applicant: Helix Diagnostics, Inc.
Product code: Code LKO
Advisory panel: Immunology
Date received: 1994-02-08
Decision date: 1994-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

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