The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Advia 120 Hematology System, In Vitro Diagnostic System.
| Device ID | K971998 |
| 510k Number | K971998 |
| Device Name: | ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca |
| Correspondent | Gabriel J Muraca BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-30 |
| Decision Date | 1997-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414575025 | K971998 | 000 |
| 00630414222899 | K971998 | 000 |
| 00630414222905 | K971998 | 000 |
| 00630414222912 | K971998 | 000 |
| 00630414222929 | K971998 | 000 |
| 00630414222943 | K971998 | 000 |
| 00630414222950 | K971998 | 000 |
| 00630414223032 | K971998 | 000 |
| 00630414224305 | K971998 | 000 |
| 00630414224329 | K971998 | 000 |
| 00630414473383 | K971998 | 000 |
| 00630414574868 | K971998 | 000 |
| 00630414222882 | K971998 | 000 |