The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Pts Panels Multi-chemistry Controls.
| Device ID | K022401 |
| 510k Number | K022401 |
| Device Name: | PTS PANELS MULTI-CHEMISTRY CONTROLS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-23 |
| Decision Date | 2002-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381930722010 | K022401 | 000 |