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 Gas Chromatography, Methamphetamine
510(k) Number K170222
Device Name Rapid Tox Cup II
Applicant
American Bio Medica Corp.
122 Smith Rd.
Kinderhook,  NY  12106
Applicant Contact MELISSA WATERHOUSE
Correspondent
American Bio Medica Corp.
122 Smith Rd.
Kinderhook,  NY  12106
Correspondent Contact MELISSA WATERHOUSE
Regulation Number862.3610
Classification Product Code
LAF  
Subsequent Product Codes
DIO   DIS   DJG   DJR   DKZ  
JXM   LCM   LDJ   LFG  
Date Received01/25/2017
Decision Date 08/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-