The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia 2120i, Advia 2120.
| Device ID | K162977 |
| 510k Number | K162977 |
| Device Name: | ADVIA 2120i, ADVIA 2120 |
| Classification | Counter, Differential Cell |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE Tarrytown, NY 10591 |
| Contact | Gerard Sadrakula |
| Correspondent | Gerard Sadrakula SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE Tarrytown, NY 10591 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-26 |
| Decision Date | 2017-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414237886 | K162977 | 000 |
| 00630414237879 | K162977 | 000 |
| 00630414019796 | K162977 | 000 |
| 00630414019789 | K162977 | 000 |
| 00630414019772 | K162977 | 000 |