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

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.

Clearance details

Applicant: Sebia
Product code: Code CFF
Advisory panel: Immunology
Date received: 2016-07-14
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

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