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 Enzyme Immunoassay, Amphetamine
510(k) Number K143500
Device Name Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
Applicant
Immunalysis Corporation
829 Towne Center Dr.
Pomona,  CA  91767
Applicant Contact Joseph Ginete
Correspondent
Immunalysis Corporation
829 Towne Center Dr.
Pomona,  CA  91767
Correspondent Contact Joseph Ginete
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DLJ   LAS  
Date Received12/10/2014
Decision Date 02/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-