Cleared Special

CAPILLARYS URINE

K080916 · Sebia · Immunology
Jul 2008
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K080916 is an FDA 510(k) clearance for the CAPILLARYS URINE, a Immunochemical, Bence-jones Protein (Class II — Special Controls, product code JKM), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on July 1, 2008, 90 days after receiving the submission on April 2, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5150.

Submission Details

510(k) Number K080916 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2008
Decision Date July 01, 2008
Days to Decision 90 days
Submission Type Special
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code JKM — Immunochemical, Bence-jones Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5150