ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT— 510(k) K952253

Name: FDA 510(k) clearance K952253
Creator: U.S. Food and Drug Administration
Published: 1995-08-24

Substantially Equivalent

Helix Diagnostics, Inc.

FDA 510(k) clearance K952253 for ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT, Substantially Equivalent on 1995-08-24. 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: 1995-05-15
Decision date: 1995-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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