K071141 is an FDA 510(k) clearance for the BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Bd Biosciences (San Jose, US). The FDA issued a Cleared decision on June 6, 2007, 43 days after receiving the submission on April 24, 2007.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K071141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2007 |
| Decision Date | June 06, 2007 |
| Days to Decision | 43 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 |