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 K021114
Device Name 'RAPIDTEC' 5A MULTIPLE DIP TEST
Applicant
American Bio Medica Corp.
9110 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact HENRY WELLS
Correspondent
American Bio Medica Corp.
9110 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact HENRY WELLS
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJG   LCM   LDJ  
Date Received04/05/2002
Decision Date 07/23/2002
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
-
-