The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Color-slide Rf.
| Device ID | K981496 |
| 510k Number | K981496 |
| Device Name: | COLOR-SLIDE RF |
| Classification | System, Test, Rheumatoid Factor |
| 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 | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-27 |
| Decision Date | 1998-06-15 |
| Summary: | summary |