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 |