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 |