Cleared Special

HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134

K022053 · Sebia · Chemistry
Jul 2002
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K022053 is an FDA 510(k) clearance for the HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134, a Electrophoretic Separation, Lipoproteins (Class I — General Controls, product code JHO), submitted by Sebia (Chelsea, US). The FDA issued a Cleared decision on July 12, 2002, 18 days after receiving the submission on June 24, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K022053 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2002
Decision Date July 12, 2002
Days to Decision 18 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHO — Electrophoretic Separation, Lipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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