The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Bd Tritest Cd3/cd4/cd45 With Bd Trucount Absolute Count Tubes, Model 340402.
| Device ID | K071141 |
| 510k Number | K071141 |
| Device Name: | BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 |
| Classification | Counter, Differential Cell |
| Applicant | BD Biosciences 2350 QUME DR. San Jose, CA 95131 -1807 |
| Contact | Nobuko Nakajima |
| Correspondent | Nobuko Nakajima BD Biosciences 2350 QUME DR. San Jose, CA 95131 -1807 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-24 |
| Decision Date | 2007-06-06 |
| Summary: | summary |