K884020 is an FDA 510(k) clearance for the COULTER CLONE B4 MONOCLONAL ANTIBODY. 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 February 3, 1989, 134 days after receiving the submission on September 22, 1988.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K884020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 1988 |
| Decision Date | February 03, 1989 |
| Days to Decision | 134 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 |