K991605 is an FDA 510(k) clearance for the CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Abbott Laboratories (Santa Clara, US). The FDA issued a Cleared decision on July 9, 1999, 60 days after receiving the submission on May 10, 1999.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K991605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 1999 |
| Decision Date | July 09, 1999 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKZ — Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |