| Test Name |
| Document |
Test Type |
Effective Date |
|
Zero Chaos, zerochaos Butalbital Drug Test Cup
|
| K152551 |
Barbiturates |
07/02/2019 |
|
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 |
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 |