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 Igg, Antigen, Antiserum, Control
510(k) Number K921575
Device Name IGG SUCLASS EIA
Applicant
Virotech Diagnostika
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
Virotech Diagnostika
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number866.5510
Classification Product Code
DEW  
Date Received04/02/1992
Decision Date 05/28/1992
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
-
-