The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia 2120 With Autoslide System, And Advia 2120i.
| Device ID | K102644 |
| 510k Number | K102644 |
| Device Name: | ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I |
| 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 | 2010-09-14 |
| Decision Date | 2011-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414582047 | K102644 | 000 |
| 00630414581965 | K102644 | 000 |
| 00630414565583 | K102644 | 000 |
| 00630414560045 | K102644 | 000 |