The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Pts Panels Chol+hdl Panel Test Strips.
| Device ID | K071593 |
| 510k Number | K071593 |
| Device Name: | PTS PANELS CHOL+HDL 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 |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-11 |
| Decision Date | 2007-10-15 |
| Summary: | summary |