Device Listing 1944308338
Listing Summary#
- Listing key
- 1944308338
- Premarket submission
- K160541
- Device
- Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
- Applicant
- Sysmex America, Inc.
- Product code
- JLW
- Decision date
- 2016-10-21