AFIAS iFOB with AFIAS-50— 510(k) K163225

Substantially Equivalent

Immunostics Inc.,

FDA 510(k) clearance K163225 for AFIAS iFOB with AFIAS-50, Substantially Equivalent on 2017-08-08. Applicant: Immunostics Inc.,.

Clearance details

Applicant
Immunostics Inc.,
Product code
Code OOX
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ocean, NJ, US
Download summary PDFView on FDA.gov ↗

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