The following data is part of a premarket notification filed by Becton Dickinson Immunocytometry Systems with the FDA for Trucount Absolute Count Tubes/counting Control Beads.
| Device ID | K970836 |
| 510k Number | K970836 |
| Device Name: | TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL 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 | 1997-02-24 |
| Decision Date | 1997-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382906630285 | K970836 | 000 |
| 00382903403356 | K970836 | 000 |
| 00382903403349 | K970836 | 000 |
| 00382906643438 | K970836 | 000 |