The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Colorslider Rubella.
Device ID | K952544 |
510k Number | K952544 |
Device Name: | COLORSLIDER RUBELLA |
Classification | Latex Agglutination Assay, Rubella |
Applicant | SERADYN, INC. 1200 MADISON AVE. Indianapolis, IN 46225 |
Contact | Martin J Weinstein |
Correspondent | Martin J Weinstein SERADYN, INC. 1200 MADISON AVE. Indianapolis, IN 46225 |
Product Code | LQN |
CFR Regulation Number | 866.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-02 |
Decision Date | 1996-01-17 |