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 Ige, Peroxidase, Antigen, Antiserum, Control
510(k) Number K821094
Device Name IP SPECIFIC E
Applicant
Diagnostic Reagent Tech.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Diagnostic Reagent Tech.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5510
Classification Product Code
DGO  
Date Received04/19/1982
Decision Date 05/07/1982
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
-
-