ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST— 510(k) K000489

Name: FDA 510(k) clearance K000489
Creator: U.S. Food and Drug Administration
Published: 2000-04-05

Substantially Equivalent

Helix Diagnostics, Inc.

FDA 510(k) clearance K000489 for ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST, Substantially Equivalent on 2000-04-05. Applicant: Helix Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Helix Diagnostics, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2000-02-14
Decision date: 2000-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.