Test Name |
Document |
Test Type |
Effective Date |
Zero Chaos, zerochaos Buprenorphine Cup Test
|
K152551 |
Buprenorphine |
07/02/2019 |
ZER HITECH EASYCUP
|
K023823 |
Urine hCG by visual color comparison tests |
05/29/2003 |
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 |
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 |
Propoxyphene |
07/11/2019 |