The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Electrophoresis Control Level 1.
| Device ID | K925326 |
| 510k Number | K925326 |
| Device Name: | ELECTROPHORESIS CONTROL LEVEL 1 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Andris Indriksons |
| Correspondent | Andris Indriksons SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-21 |
| Decision Date | 1993-03-26 |