The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Bd Multitest 6-color Tbnk Reagent, Model 644611.
| Device ID | K090967 |
| 510k Number | K090967 |
| Device Name: | BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 |
| Classification | Counter, Differential Cell |
| Applicant | BD Biosciences 2350 QUME DR. San Jose, CA 95131 -1807 |
| Contact | Katy Campbell |
| Correspondent | Katy Campbell 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 | 2009-04-06 |
| Decision Date | 2009-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382906629678 | K090967 | 000 |
| 00382906446114 | K090967 | 000 |
| 00382903403349 | K090967 | 000 |