The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Bd Multitest 6-color Tbnk Reagent With Bd Trucount Tubes With Models 337 And 166.
| Device ID | K060375 |
| 510k Number | K060375 |
| Device Name: | BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 |
| Classification | Counter, Differential Cell |
| Applicant | BD Biosciences 2350 QUME DR. San Jose, CA 95131 -1807 |
| Contact | Carter Navarro |
| Correspondent | Carter Navarro 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 | 2006-02-13 |
| Decision Date | 2006-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382906629951 | K060375 | 000 |
| 00382903371662 | K060375 | 000 |