Polymer Technology Systems, Inc. · Class II · Cleared Oct 2, 2014
| K-number | K142302 |
| Device name | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System |
| Applicant | Polymer Technology Systems, Inc. |
| Product code | CGA |
| Device class | Class II |
| Decision date | Oct 2, 2014 |
| Decision | Substantially Equivalent |
| Regulation | 862.1345 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov