IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM— 510(k) K870903

Name: FDA 510(k) clearance K870903
Creator: U.S. Food and Drug Administration
Published: 1987-05-14

Substantially Equivalent

Immunomedics, Inc.

FDA 510(k) clearance K870903 for IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM, Substantially Equivalent on 1987-05-14. Applicant: Immunomedics, Inc.. Device class: 2.

Clearance details

Applicant: Immunomedics, Inc.
Product code: Code LRM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1987-03-05
Decision date: 1987-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, NJ, US

Download summary PDF View on FDA.gov ↗

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