The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Bd Tritest Cd3/cd4/cd45, Model 340383.
| Device ID | K071143 |
| 510k Number | K071143 |
| Device Name: | BD TRITEST CD3/CD4/CD45, MODEL 340383 |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903403837 | K071143 | 000 |