The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Bd Facscount Cd4 Reagents With Model 339010.
| Device ID | K081213 |
| 510k Number | K081213 |
| Device Name: | BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-30 |
| Decision Date | 2008-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903390113 | K081213 | 000 |
| 00382903390106 | K081213 | 000 |