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 K013314
Device Name OPIATES
Applicant
Abbott Laboratories
1920 Hurd Dr.
Irving,  TX  75038
Applicant Contact ALICIA SIMPSON
Correspondent
Abbott Laboratories
1920 Hurd Dr.
Irving,  TX  75038
Correspondent Contact ALICIA SIMPSON
Regulation Number862.3650
Classification Product Code
DJG  
Date Received10/04/2001
Decision Date 03/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-