Cleared Traditional

HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207

K974854 · Morax · Chemistry
Oct 1998
Decision
282d
Days
Class 1
Risk

About This 510(k) Submission

K974854 is an FDA 510(k) clearance for the HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207, a Electrophoretic Separation, Lipoproteins (Class I — General Controls, product code JHO), submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on October 7, 1998, 282 days after receiving the submission on December 29, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K974854 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1997
Decision Date October 07, 1998
Days to Decision 282 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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