The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Pts Panels Ldl Cholesterol Test Strips.
| Device ID | K040693 |
| 510k Number | K040693 |
| Device Name: | PTS PANELS LDL CHOLESTEROL TEST STRIPS |
| Classification | System, Test, Low Density, Lipoprotein |
| 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 | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-17 |
| Decision Date | 2004-07-06 |
| Summary: | summary |