The following data is part of a premarket notification filed by Seragen Diagnostics, Inc. with the FDA for Seratest Rf Latex Determination.
| Device ID | K840863 |
| 510k Number | K840863 |
| Device Name: | SERATEST RF LATEX DETERMINATION |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | SERAGEN DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1984-04-04 |