IMMUSTRIP(TM) SM ELISA TEST SYSTEM— 510(k) K873741

Name: FDA 510(k) clearance K873741
Creator: U.S. Food and Drug Administration
Published: 1987-11-04

Substantially Equivalent

Immunomedics, Inc.

FDA 510(k) clearance K873741 for IMMUSTRIP(TM) SM ELISA TEST SYSTEM, Substantially Equivalent on 1987-11-04. Applicant: Immunomedics, Inc.. Device class: 2.

Clearance details

Applicant: Immunomedics, Inc.
Product code: Code LKP
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1987-09-16
Decision date: 1987-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, NJ, US

Download summary PDF View on FDA.gov ↗

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