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 |