The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Bioscanner Plus; Lipid Panel Test Strips.
| Device ID | K013173 |
| 510k Number | K013173 |
| Device Name: | BIOSCANNER PLUS; LIPID PANEL TEST STRIPS |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. Indianapolis, IN 46268 |
| Contact | Margo Enright |
| Correspondent | Margo Enright POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. Indianapolis, IN 46268 |
| Product Code | CHH |
| Subsequent Product Code | JGY |
| Subsequent Product Code | LBR |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-24 |
| Decision Date | 2001-10-22 |
| Summary: | summary |