The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Mtm Bioscanner Hdl, Model # Bsa450, Bsa460, Bsa470.
| Device ID | K990247 |
| 510k Number | K990247 |
| Device Name: | MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 |
| Classification | Ldl & Vldl Precipitation, Hdl |
| 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 | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-26 |
| Decision Date | 1999-05-28 |