The following data is part of a premarket notification filed by Becton Dickinson Immunocytometry Systems with the FDA for Tritest Reagent Cd3 Fitc/cd16+cd56 Pe/cd45 Percp;with Trucount Absolute Count Tubes.
| Device ID | K971110 |
| 510k Number | K971110 |
| Device Name: | TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES |
| 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 | 1997-03-26 |
| Decision Date | 1997-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903403004 | K971110 | 000 |