The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Rad-291.
| Device ID | K781554 |
| 510k Number | K781554 |
| Device Name: | RAD-291 |
| Classification | Nephelometer, For Clinical Use |
| Applicant | ORGANON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JQX |
| CFR Regulation Number | 862.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-11 |
| Decision Date | 1978-10-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RAD-291 73180529 1125755 Dead/Cancelled |
ORGANON INC. 1978-07-31 |