Cleared Special

HYDRAGEL CSF ISOFOCUSING KITS

K033277 · Morax · Immunology
Nov 2003
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K033277 is an FDA 510(k) clearance for the HYDRAGEL CSF ISOFOCUSING KITS, a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II — Special Controls, product code CFF), submitted by Morax (Norcross, US). The FDA issued a Cleared decision on November 4, 2003, 25 days after receiving the submission on October 10, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K033277 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2003
Decision Date November 04, 2003
Days to Decision 25 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CFF — Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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