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, Opiates
510(k) Number K123799
Device Name PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR
Applicant
Psychemedics Corp.
5832 Uplander Way
Culver City,  CA  90230
Applicant Contact VIRGINIA HILL
Correspondent
Psychemedics Corp.
5832 Uplander Way
Culver City,  CA  90230
Correspondent Contact VIRGINIA HILL
Regulation Number862.3650
Classification Product Code
DJG  
Date Received12/10/2012
Decision Date 02/08/2013
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
-
-