The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Modification To Bayer Advia 2120 Hematology Analyzer With Autoslide System.
| Device ID | K051693 |
| 510k Number | K051693 |
| Device Name: | MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Andrea Holle |
| Correspondent | Andrea Holle BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | GKL |
| Subsequent Product Code | GKZ |
| Subsequent Product Code | KPA |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-23 |
| Decision Date | 2005-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414517360 | K051693 | 000 |
| 00630414560595 | K051693 | 000 |
| 00630414000220 | K051693 | 000 |