The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Bioscanner 2000.
| Device ID | K013068 |
| 510k Number | K013068 |
| Device Name: | BIOSCANNER 2000 |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-28 |
| Decision Date | 2001-11-20 |
| Summary: | summary |