Device Listing 2003894202
Listing Summary#
- Listing key
- 2003894202
- Premarket submission
- K083868
- Device
- ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Product code
- NHX
- Decision date
- 2009-09-25