Cleared Traditional

CAPILLARYS URINE (PN 2012)

K070486 · Sebia, Inc. · Immunology
Dec 2007
Decision
304d
Days
Class 2
Risk

About This 510(k) Submission

K070486 is an FDA 510(k) clearance for the CAPILLARYS URINE (PN 2012), a Immunochemical, Bence-jones Protein (Class II — Special Controls, product code JKM), submitted by Sebia, Inc. (Norcross, US). The FDA issued a Cleared decision on December 21, 2007, 304 days after receiving the submission on February 20, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5150.

Submission Details

510(k) Number K070486 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2007
Decision Date December 21, 2007
Days to Decision 304 days
Submission Type Traditional
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