The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Ria System For Human Fe-ritin.
| Device ID | K781527 |
| 510k Number | K781527 |
| Device Name: | RIA SYSTEM FOR HUMAN FE-RITIN |
| Classification | Radioimmunoassay (two-site Solid Phase), Ferritin |
| Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JMG |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-05 |
| Decision Date | 1978-10-03 |