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 K890774
Device Name GIARDEIA(TM)
Applicant
Antibodies, Inc.
P.O. Box 1560
Davis,  CA  95617
Applicant Contact BANOVITZ, PH.D.
Correspondent
Antibodies, Inc.
P.O. Box 1560
Davis,  CA  95617
Correspondent Contact BANOVITZ, PH.D.
Regulation Number866.3220
Classification Product Code
KHW  
Date Received02/15/1989
Decision Date 04/04/1989
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
-
-