The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Automated Differential Cell Counter.
| Device ID | BK150307 |
| 510k Number | BK150307 |
| Device Name: | Automated Differential Cell Counter |
| Classification | Flow Cytometric Reagents And Accessories. |
| Applicant | BD Biosciences 2350 Qume Drive San Jose, CA 95131 US |
| Product Code | OYE |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-24 |
| Decision Date | 2016-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382906624185 | BK150307 | 000 |
| 00382906624178 | BK150307 | 000 |
| 00382906624161 | BK150307 | 000 |
| 00382906624154 | BK150307 | 000 |
| 00382906624147 | BK150307 | 000 |
| 00382906624130 | BK150307 | 000 |
| 00382906623867 | BK150307 | 000 |
| 00382906605610 | BK150307 | 000 |