The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Pts Panels Hdl Cholesterol Test Strips.
| Device ID | K060617 |
| 510k Number | K060617 |
| Device Name: | PTS PANELS HDL CHOLESTEROL TEST STRIPS |
| Classification | Lipoprotein, High Density, Hdl, Over The Counter |
| 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 | NAQ |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-08 |
| Decision Date | 2006-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381931788015 | K060617 | 000 |
| 00381931714014 | K060617 | 000 |