• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

OTC - Over The Counter

  • 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
 

 
 < 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 > 
 
500 records meeting your search criteria returned . please narrow your search.
New Searchexport reports to excelExport to Excel | helpHelp
Test Name
Document Test Type Effective Date
Zenith Diagnostics UltraTRAK Ultimate Blood Glucose Monitoring System  
K100322 Glucose monitoring devices (FDA cleared/home use) 06/04/2015
Zenith Diagnostics UltraTRAK Complete Blood Glucose Monitoring System  
K063212 Glucose 09/28/2015
YOUR 1ST CHOICE FOR VALUE! TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703/A003 Glucose monitoring devices (FDA cleared/home use) 08/22/2003
Xiamen USEFUL Imp And Exp CO., LTD, Diagnostic Test One Step Rapid Test DipCard  
K163704 Amphetamines 07/11/2019
Xiamen USEFUL Imp And Exp CO., LTD, Diagnostic Test One Step Rapid Test DipCard  
K163704 Barbiturates 07/11/2019
Xiamen USEFUL Imp And Exp CO., LTD, Diagnostic Test One Step Rapid Test DipCard  
K163704 Benzodiazepines 07/11/2019
Xiamen USEFUL Imp And Exp CO., LTD, Diagnostic Test One Step Rapid Test DipCard  
K163704 Buprenorphine 07/11/2019
Xiamen USEFUL Imp And Exp CO., LTD, Diagnostic Test One Step Rapid Test DipCard  
K163704 Cannabinoids (THC) 07/11/2019
Xiamen USEFUL Imp And Exp CO., LTD, Diagnostic Test One Step Rapid Test DipCard  
K163704 Cocaine metabolites 07/11/2019
Xiamen USEFUL Imp And Exp CO., LTD, Diagnostic Test One Step Rapid Test DipCard  
K163704 Phencyclidine (PCP) 07/11/2019
-
-