Cleared Traditional

CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT

K130500 · Sebia · Immunology

Jul 2013

Decision

150d

Days

Class 1

Risk

About This 510(k) Submission

K130500 is an FDA 510(k) clearance for the CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT, a Electrophoretic, Protein Fractionation (Class I — General Controls, product code CEF), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on July 26, 2013, 150 days after receiving the submission on February 26, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1630.

Submission Details

510(k) Number	K130500 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 2013
Decision Date	July 26, 2013
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF