Cleared Traditional

HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT

K972591 · Morax · Immunology
Mar 1998
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K972591 is an FDA 510(k) clearance for the HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT, a Immunochemical, Bence-jones Protein (Class II — Special Controls, product code JKM), submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on March 4, 1998, 236 days after receiving the submission on July 11, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5150.

Submission Details

510(k) Number K972591 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1997
Decision Date March 04, 1998
Days to Decision 236 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code JKM — Immunochemical, Bence-jones Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5150

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