The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Bioscanner Triglycerides Test Strips.
| Device ID | K000586 |
| 510k Number | K000586 |
| Device Name: | BIOSCANNER TRIGLYCERIDES TEST STRIPS |
| Classification | Colorimetric Method, Triglycerides |
| 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 | JGY |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-22 |
| Decision Date | 2000-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381931789012 | K000586 | 000 |