Cleared Traditional

ALPHA-2 MACROGLOBULIN TEST RID KIT

K914389 · The Binding Site, Ltd. · Immunology
Dec 1991
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K914389 is an FDA 510(k) clearance for the ALPHA-2 MACROGLOBULIN TEST RID KIT, a Alpha-2-macroglobulin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEB), submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 20, 1991, 80 days after receiving the submission on October 1, 1991. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5620.

Submission Details

510(k) Number K914389 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1991
Decision Date December 20, 1991
Days to Decision 80 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DEB — Alpha-2-macroglobulin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5620

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