Device Listing 1917963340
Listing Summary#
- Listing key
- 1917963340
- Premarket submission
- K093957
- Device
- ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
- Applicant
- Fujirebio Diagnostics,Inc.
- Product code
- OIU
- Decision date
- 2010-03-18