The following data is part of a premarket notification filed by United Diagnostics, Inc. with the FDA for Stat-trak Plus Liquid Chemistry Controls 1,2 & 3.
| Device ID | K843986 |
| 510k Number | K843986 |
| Device Name: | STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | UNITED DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Contact | Norman Kleinman |
| Correspondent | Norman Kleinman UNITED DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-11 |
| Decision Date | 1984-11-27 |