K895917 is an FDA 510(k) clearance for the CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Coulter Immunology (Hialeah, US). The FDA issued a Cleared decision on December 29, 1989, 80 days after receiving the submission on October 10, 1989.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K895917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 1989 |
| Decision Date | December 29, 1989 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GKZ — Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |