The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Bioscanner Plus.
| Device ID | K014099 |
| 510k Number | K014099 |
| Device Name: | BIOSCANNER PLUS |
| Classification | System, Test, Blood Glucose, 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 | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-13 |
| Decision Date | 2001-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381931782013 | K014099 | 000 |
| 00381931757011 | K014099 | 000 |
| 00381931709010 | K014099 | 000 |