The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Calibrite Percp-cy5.5 Beads And Facscomp Software.
| Device ID | K000897 |
| 510k Number | K000897 |
| Device Name: | CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE |
| Classification | Counter, Differential Cell |
| Applicant | BD Biosciences 2350 QUME DR. San Jose, CA 95131 -1807 |
| Contact | Cindy Morrow |
| Correspondent | Cindy Morrow 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 | 2000-03-21 |
| Decision Date | 2000-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903450367 | K000897 | 000 |
| 00382903450350 | K000897 | 000 |
| 00382903431151 | K000897 | 000 |