The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Mtm Bioscanner Hdl Test Strips, Over The Counter (otc).
| Device ID | K993377 |
| 510k Number | K993377 |
| Device Name: | MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-28 |
| Decision Date | 2000-01-13 |