K982166 is an FDA 510(k) clearance for the CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on November 5, 1998, 139 days after receiving the submission on June 19, 1998.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K982166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1998 |
| Decision Date | November 05, 1998 |
| Days to Decision | 139 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 |