The following data is part of a premarket notification filed by Becton Dickinson Immunocytometry Systems with the FDA for Tritest Reagent Cd3 Fitc/cd4 Pe/cd45 Percp.
| Device ID | K946055 |
| 510k Number | K946055 |
| Device Name: | TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP |
| 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 | 1994-11-28 |
| Decision Date | 1996-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903475278 | K946055 | 000 |
| 00382903475261 | K946055 | 000 |