Year: | 2013 | |||
---|---|---|---|---|
Author’s Country: | USA | |||
# BGMs: | 7 | |||
% ISO 2003 | 43% | |||
% ISO 2013 | 14% | |||
% FDA Cleared: | 71% | |||
% FDA Cleared Meeting ISO 2013: | 20% | |||
% FDA Cleared Meeting ISO 2003: | 60% | |||
Meter Name | Company | Cleared? | ISO 2003 | ISO 2013 |
Accu-Chek Aviva Plus | Roche Diagnostics | Yes | Yes | Yes |
Advocate Redo-Code | TaiDoc Technology Corp | Yes | No | No |
Element | Infopia Co | Yes | Yes | No |
Embrace | Apex Biotechnology Corp | No | No | No |
Prodigy Voice | Diagnostic Devices Inc | Yes | No | No |
TRUEbalance | Nipro Diagnostics | Yes | No | No |
WaveSense Presto | AgaMatrix | No | Yes | No |