Alinity m STI Assay— 510(k) K222379

Substantially Equivalent

Abbott Molecular, Inc.

FDA 510(k) clearance K222379 for Alinity m STI Assay, Substantially Equivalent on 2023-03-03. Applicant: Abbott Molecular, Inc..

Clearance details

Applicant
Abbott Molecular, Inc.
Product code
Code QEP
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Des Plaines, IL, US
Download summary PDFView on FDA.gov ↗

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