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, Cannabinoids
510(k) Number K994138
Device Name FIRST CHECK HOME DRUG TEST PANEL 3
Applicant
Worldwide Medical Corp.
1900 K St. NW
Washington,  DC  20006 -1108
Applicant Contact LARRY R PILOT
Correspondent
Worldwide Medical Corp.
1900 K St. NW
Washington,  DC  20006 -1108
Correspondent Contact LARRY R PILOT
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIO   LAF  
Date Received12/07/1999
Decision Date 06/23/2000
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
-
-