The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Atellica Im Ferritin Assay.
| Device ID | K171642 |
| 510k Number | K171642 |
| Device Name: | Atellica IM Ferritin Assay |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Ave. Tarrytown, NY 10591 |
| Contact | Kira Gordon |
| Correspondent | Kira Gordon Siemens Healthcare Diagnostics Inc. 511 Benedict Ave. Tarrytown, NY 10591 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-02 |
| Decision Date | 2017-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598932 | K171642 | 000 |
| 00630414598925 | K171642 | 000 |
| 00630414294162 | K171642 | 000 |