The following data is part of a premarket notification filed by Becton Dickinson Immunocytometry Systems with the FDA for Autocomp(tm) Software And Calibrite(tm) Beads.
| Device ID | K925274 |
| 510k Number | K925274 |
| Device Name: | AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS |
| Classification | Counter, Differential Cell |
| Applicant | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR. San Jose, CA 95131 -1807 |
| Contact | Anna Longwell |
| Correspondent | Anna Longwell BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 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 | 1992-10-19 |
| Decision Date | 1994-09-30 |