The following data is part of a premarket notification filed by Eurogenetics with the FDA for Eurogenetics Crp Elisa.
| Device ID | K872539 |
| 510k Number | K872539 |
| Device Name: | EUROGENETICS CRP ELISA |
| Classification | System, Test, C-reactive Protein |
| Applicant | EUROGENETICS 583 MOUNTAIN AVE. North Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff EUROGENETICS 583 MOUNTAIN AVE. North Caldwell, NJ 07006 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-29 |
| Decision Date | 1987-10-20 |