Cleared Traditional

IMMUSTRIP(TM) SM ELISA TEST SYSTEM

K873741 · Immunomedics, Inc. · Immunology
Nov 1987
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K873741 is an FDA 510(k) clearance for the IMMUSTRIP(TM) SM ELISA TEST SYSTEM, a Anti-sm Antibody, Antigen And Control (Class II — Special Controls, product code LKP), submitted by Immunomedics, Inc. (Newark, US). The FDA issued a Cleared decision on November 4, 1987, 49 days after receiving the submission on September 16, 1987. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K873741 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 1987
Decision Date November 04, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code LKP — Anti-sm Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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