The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Ferritin Controls Code Qas.104.
| Device ID | K800657 |
| 510k Number | K800657 |
| Device Name: | FERRITIN CONTROLS CODE QAS.104 |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-25 |
| Decision Date | 1980-04-16 |