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.,. Device class: 2.

Clearance details

Applicant: Immunostics Inc.,
Product code: Code OOX
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2016-11-17
Decision date: 2017-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ocean, NJ, US

Download summary PDF View on FDA.gov ↗

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