The following data is part of a premarket notification filed by Becton Dickinson Immunocytometry Systems with the FDA for Tritest Cd3 Fitc/cd19 Pe/cd45 Percp Reagent With Trucount Absolute Count Tubes.
| Device ID | K970742 |
| 510k Number | K970742 |
| Device Name: | TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES |
| Classification | Counter, Differential Cell |
| Applicant | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR. San Jose, CA 95131 -1807 |
| Contact | Anna Longwell, Esq. |
| Correspondent | Anna Longwell, Esq. 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 | 1997-02-28 |
| Decision Date | 1997-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903403813 | K970742 | 000 |