The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for 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 C.
| Device ID | K142302 |
| 510k 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 C |
| Classification | Glucose Oxidase, Glucose |
| Applicant | Polymer Technology Systems, Inc. 7736 Zionsville Rd. Indianapolis, IN 46268 |
| Contact | Jack Rogers |
| Correspondent | Jack Rogers Polymer Technology Systems, Inc. 7736 Zionsville Rd. Indianapolis, IN 46268 |
| Product Code | CGA |
| Subsequent Product Code | CHH |
| Subsequent Product Code | JGY |
| Subsequent Product Code | LBR |
| Subsequent Product Code | MRR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-18 |
| Decision Date | 2014-10-02 |
| Summary: | summary |