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 K983770
Device Name 'RAPID DRUG SCREEN' 9-PANEL
Applicant
American Bio Medica Corp.
1001 G St., NW
Suite 500 W.
Washington,  DC  20001
Applicant Contact JOHN B DUBECK
Correspondent
American Bio Medica Corp.
1001 G St., NW
Suite 500 W.
Washington,  DC  20001
Correspondent Contact JOHN B DUBECK
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJE   JXM   LAF  
LCM   LDJ   LFG  
Date Received10/26/1998
Decision Date 12/31/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-