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

Name: FDA 510(k) clearance K940588
Creator: U.S. Food and Drug Administration
Published: 1994-04-20

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.. Device class: 2.

Clearance details

Applicant: Helix Diagnostics, Inc.
Product code: Code LKO
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1994-02-08
Decision date: 1994-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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