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 Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
510(k) Number K853448
Device Name HILLCREST AMEBIASIS IHA TEST
Applicant
Hillcrest Biologicals
10703 Progress Way
Cypress,  CA  90630
Applicant Contact FULLER
Correspondent
Hillcrest Biologicals
10703 Progress Way
Cypress,  CA  90630
Correspondent Contact FULLER
Regulation Number866.3220
Classification Product Code
KHW  
Date Received08/16/1985
Decision Date 08/28/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-