CAPI 3 Immunotyping, Capillarys 3 Tera— 510(k) K192095

Substantially Equivalent

Sebia

FDA 510(k) clearance K192095 for CAPI 3 Immunotyping, Capillarys 3 Tera, Substantially Equivalent on 2019-11-01. Applicant: Sebia. Device class: 2.

Clearance details

Applicant: Sebia
Product code: Code CFF
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2019-08-05
Decision date: 2019-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, 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.