Cleared Traditional

IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM

K870903 · Immunomedics, Inc. · Immunology
May 1987
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K870903 is an FDA 510(k) clearance for the IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM, a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II — Special Controls, product code LRM), submitted by Immunomedics, Inc. (Newark, US). The FDA issued a Cleared decision on May 14, 1987, 70 days after receiving the submission on March 5, 1987. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K870903 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1987
Decision Date May 14, 1987
Days to Decision 70 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code LRM — Anti-dna Antibody (enzyme-labeled), Antigen, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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