The following data is part of a premarket notification filed by Becton Dickinson Immunocytometry Systems with the FDA for Multitest Cd3/cd16+56/cd45/cd19 Reagent And Multitest Imk Kit Lysing Solution.
| Device ID | K980858 |
| 510k Number | K980858 |
| Device Name: | MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION |
| Classification | Counter, Differential Cell |
| Applicant | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR. San Jose, CA 95131 -1807 |
| Contact | Cindy Morrow |
| Correspondent | Cindy Morrow 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 | 1998-03-05 |
| Decision Date | 1998-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382906629654 | K980858 | 000 |
| 00382903405039 | K980858 | 000 |
| 00382903405008 | K980858 | 000 |