CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL— 510(k) K161928

Name: FDA 510(k) clearance K161928
Creator: U.S. Food and Drug Administration
Published: 2016-12-21

Substantially Equivalent

Sebia

FDA 510(k) clearance K161928 for CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL, Substantially Equivalent on 2016-12-21. 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: 2016-07-14
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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