The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Advia 120 Hematology System, Cerebrospinal Fluid Method.
| Device ID | K022331 |
| 510k Number | K022331 |
| Device Name: | ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | GKL |
| Subsequent Product Code | GKZ |
| Subsequent Product Code | JPK |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-18 |
| Decision Date | 2002-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414473444 | K022331 | 000 |