The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Bd Facscanto Ii Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962.
| Device ID | K062087 |
| 510k Number | K062087 |
| Device Name: | BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2006-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382906578808 | K062087 | 000 |
| 00382906577696 | K062087 | 000 |
| 00382903420650 | K062087 | 000 |
| 00382903389605 | K062087 | 000 |
| 00382906641243 | K062087 | 000 |
| 00382906641106 | K062087 | 000 |