510(k) K951850— ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT

Substantially Equivalent

Helix Diagnostics, Inc.

Clearance details

Applicant
Helix Diagnostics, Inc.
Product code
Code LJM
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Sacramento, CA, US
Download summary PDFView on FDA.gov ↗

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