The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Cell-dyn 3500 System With Immature Reticulocyte Fraction (irf), Cell-dyn 3700 System With Immature Reticulocyte Fraction.
| Device ID | K991605 |
| 510k Number | K991605 |
| Device Name: | CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION |
| Classification | Counter, Differential Cell |
| Applicant | ABBOTT LABORATORIES 5440 PATRICK HENRY DR. Santa Clara, CA 95054 |
| Contact | Michelle B Roeding |
| Correspondent | Michelle B Roeding ABBOTT LABORATORIES 5440 PATRICK HENRY DR. Santa Clara, CA 95054 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-10 |
| Decision Date | 1999-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740002732 | K991605 | 000 |
| 00380740002725 | K991605 | 000 |
| 00380740002695 | K991605 | 000 |
| 00380740002688 | K991605 | 000 |