The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Electrophoresis Control.
Device ID | K910160 |
510k Number | K910160 |
Device Name: | ELECTROPHORESIS CONTROL |
Classification | Calibrator, Secondary |
Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
Contact | Michael J Sullivan |
Correspondent | Michael J Sullivan SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
Product Code | JIT |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-15 |
Decision Date | 1991-02-27 |