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 Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K852231
Device Name ANA/LITE-HEP-2 TEST SYSTEM
Applicant
Immuno-Products Industries
P.O. Box 286
So. Bound Brook,  NJ  08880
Applicant Contact HOWARD RUBINSTEIN
Correspondent
Immuno-Products Industries
P.O. Box 286
So. Bound Brook,  NJ  08880
Correspondent Contact HOWARD RUBINSTEIN
Regulation Number866.5100
Classification Product Code
LJM  
Date Received05/22/1985
Decision Date 07/10/1985
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
-
-