Cleared Traditional

IMMUNOMEDICS SERUM ELISA TEST SYSTEM

K861362 · Immunomedics, Inc. · Immunology
Jun 1986
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K861362 is an FDA 510(k) clearance for the IMMUNOMEDICS SERUM ELISA TEST SYSTEM, a Complement C3, Antigen, Antiserum, Control (Class II — Special Controls, product code CZW), submitted by Immunomedics, Inc. (Newark, US). The FDA issued a Cleared decision on June 6, 1986, 57 days after receiving the submission on April 10, 1986. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K861362 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 1986
Decision Date June 06, 1986
Days to Decision 57 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code CZW — Complement C3, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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