DeviceClearance

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

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..

Clearance details

Applicant
Helix Diagnostics, Inc.
Product code
Code LLL
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Sacramento, CA, US
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