Device Listing 1516519046
Listing Summary#
- Listing key
- 1516519046
- Premarket submission
- K162282
- Device
- CardioChek Plus Test System, CardioChek Home Test System
- Applicant
- Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
- Product code
- CGA
- Decision date
- 2016-12-22