The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Cell-dyn 3200 System.
| Device ID | K972354 |
| 510k Number | K972354 |
| Device Name: | ABBOTT CELL-DYN 3200 SYSTEM |
| Classification | Counter, Differential Cell |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Sue E Luptovic |
| Correspondent | Sue E Luptovic ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-24 |
| Decision Date | 1997-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740007317 | K972354 | 000 |
| 00380740007300 | K972354 | 000 |
| 00380740007270 | K972354 | 000 |
| 00380740007263 | K972354 | 000 |