Cleared Traditional

BETA-2 MICROGLOBULIN EIA

K901333 · Serex, Inc. · Immunology
Apr 1990
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K901333 is an FDA 510(k) clearance for the BETA-2 MICROGLOBULIN EIA, a System, Test, Beta-2-microglobulin Immunological (Class II — Special Controls, product code JZG), submitted by Serex, Inc. (Tenafly, US). The FDA issued a Cleared decision on April 2, 1990, 13 days after receiving the submission on March 20, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K901333 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1990
Decision Date April 02, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JZG — System, Test, Beta-2-microglobulin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5630

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