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 |