Cleared Traditional

HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)

K011113 · Sebia · Chemistry
Jun 2001
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K011113 is an FDA 510(k) clearance for the HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132), a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II — Special Controls, product code CIN), submitted by Sebia (Chelsea, US). The FDA issued a Cleared decision on June 13, 2001, 63 days after receiving the submission on April 11, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K011113 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2001
Decision Date June 13, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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