K030408 is an FDA 510(k) clearance for the CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on March 4, 2003, 25 days after receiving the submission on February 7, 2003.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K030408 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2003 |
| Decision Date | March 04, 2003 |
| Days to Decision | 25 days |
| Submission Type | Special |
| 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 |