Cleared Traditional

HYDRAGEL 6 CSF KIT

K981048 · Morax · Immunology
Oct 1998
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K981048 is an FDA 510(k) clearance for the HYDRAGEL 6 CSF KIT, a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II — Special Controls, product code CFF), submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on October 7, 1998, 201 days after receiving the submission on March 20, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K981048 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1998
Decision Date October 07, 1998
Days to Decision 201 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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