The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Chemistry Ferritin (frt) Method.
| Device ID | K110736 |
| 510k Number | K110736 |
| Device Name: | ADVIA CHEMISTRY FERRITIN (FRT) METHOD |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10509 |
| Contact | Kira Gordon |
| Correspondent | Kira Gordon Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10509 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-16 |
| Decision Date | 2011-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414590189 | K110736 | 000 |
| 00630414586069 | K110736 | 000 |