K884346 is an FDA 510(k) clearance for the CYTO-STAT/COULTER CLONE T11-RD1/B1-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 27, 1988, 74 days after receiving the submission on October 14, 1988.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K884346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1988 |
| Decision Date | December 27, 1988 |
| Days to Decision | 74 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 |