Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Anti-Sm Antibody, Antigen And Control
510(k) Number K873741
Device Name IMMUSTRIP(TM) SM ELISA TEST SYSTEM
Applicant
Immunomedics, Inc.
5 Bruce St., Bldg. #5
Newark,  NJ  07103
Applicant Contact LINDA L NARDONE,PHD
Correspondent
Immunomedics, Inc.
5 Bruce St., Bldg. #5
Newark,  NJ  07103
Correspondent Contact LINDA L NARDONE,PHD
Regulation Number866.5100
Classification Product Code
LKP  
Date Received09/16/1987
Decision Date 11/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-