Cleared Traditional

BETA-2 MICROGLOBULIN EIA

K890694 · Serex, Inc. · Immunology
Mar 1989
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K890694 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. (Englewood, US). The FDA issued a Cleared decision on March 16, 1989, 34 days after receiving the submission on February 10, 1989. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K890694 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1989
Decision Date March 16, 1989
Days to Decision 34 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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