Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Becton Dickinson Immunocytometry Systems — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
244 daysmedian FDA review time
417 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040725 | BD FACSCANTO SYSTEM | Becton Dickinson Immunocytometry Systems | 2004-09-10 | 172 | 2 |
| K040026 | BD FACS 7-COLOR SETUP BEADS | Becton Dickinson Immunocytometry Systems | 2004-09-10 | 247 | 3 |
| K980858 | MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KI | Becton Dickinson Immunocytometry Systems | 1998-05-22 | 78 | 1 |
| K974360 | MULTITEST CD3/CD8/CD45/CD4 | Becton Dickinson Immunocytometry Systems | 1998-03-11 | 112 | 0 |
| K973483 | FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOME | Becton Dickinson Immunocytometry Systems | 1998-02-17 | 155 | 1 |
| K971205 | TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT AB | Becton Dickinson Immunocytometry Systems | 1997-12-01 | 244 | 0 |
| K971110 | TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOU | Becton Dickinson Immunocytometry Systems | 1997-11-25 | 244 | 0 |
| K970326 | TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABS | Becton Dickinson Immunocytometry Systems | 1997-11-21 | 297 | 0 |
| K965053 | TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUT | Becton Dickinson Immunocytometry Systems | 1997-11-21 | 338 | 0 |
| K970742 | TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT AB | Becton Dickinson Immunocytometry Systems | 1997-10-22 | 236 | 0 |
| K970836 | TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS | Becton Dickinson Immunocytometry Systems | 1997-08-26 | 183 | 0 |
| K963963 | MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSI | Becton Dickinson Immunocytometry Systems | 1996-12-12 | 71 | 1 |
| K946055 | TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP | Becton Dickinson Immunocytometry Systems | 1996-02-20 | 449 | 1 |
| K950342 | TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP | Becton Dickinson Immunocytometry Systems | 1996-02-20 | 389 | 0 |
| K953302 | FACS LOADER SYSTEM | Becton Dickinson Immunocytometry Systems | 1995-11-20 | 129 | 0 |
| K950057 | TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP | Becton Dickinson Immunocytometry Systems | 1995-08-22 | 229 | 0 |
| K925274 | AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS | Becton Dickinson Immunocytometry Systems | 1994-09-30 | 711 | 0 |
| K933486 | FASCOUNT SYSTME | Becton Dickinson Immunocytometry Systems | 1994-09-09 | 417 | 1 |
| K923790 | FACSORT FLOW CYTOMETER | Becton Dickinson Immunocytometry Systems | 1993-09-01 | 400 | 0 |
| K924587 | SIMULTEST CD3/ANTI-HLA-DR | Becton Dickinson Immunocytometry Systems | 1993-08-05 | 329 | 0 |
| K890349 | SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN | Becton Dickinson Immunocytometry Systems | 1989-12-29 | 339 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda