CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT— 510(k) K130500

Name: FDA 510(k) clearance K130500
Creator: U.S. Food and Drug Administration
Published: 2013-07-26

Substantially Equivalent

Sebia

FDA 510(k) clearance K130500 for CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT, Substantially Equivalent on 2013-07-26. Applicant: Sebia. Device class: 1.

Clearance details

Applicant: Sebia
Product code: Code CEF
Device class: Class 1
Regulation: 21 CFR 862.1630
Advisory panel: Clinical Chemistry
Date received: 2013-02-26
Decision date: 2013-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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