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, Carbamazepine
510(k) Number K862916
Device Name EZ-SCREEN: CANNABINOID
Applicant
Environmental Diagnostics, Inc.
P.O. Box 908
1238 Anthony Rd.
Burlington,  NC  27215
Applicant Contact CAROLINE H WINSLOW
Correspondent
Environmental Diagnostics, Inc.
P.O. Box 908
1238 Anthony Rd.
Burlington,  NC  27215
Correspondent Contact CAROLINE H WINSLOW
Regulation Number862.3645
Classification Product Code
KLT  
Date Received08/01/1986
Decision Date 01/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-