Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Becton Dickinson Advanced Diagnostics — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
146 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935667 | QTEST(R) STREP | Becton Dickinson Advanced Diagnostics | 1994-04-21 | 146 | 0 |
| K931294 | IQ TUPTAKE ASSAY | Becton Dickinson Advanced Diagnostics | 1993-07-22 | 129 | 0 |
| K931295 | IQ TT4 ASSAY | Becton Dickinson Advanced Diagnostics | 1993-07-20 | 127 | 0 |
| K926356 | PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG | Becton Dickinson Advanced Diagnostics | 1993-03-18 | 87 | 0 |
| K925132 | BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE | Becton Dickinson Advanced Diagnostics | 1992-12-28 | 76 | 0 |
| K923673 | PRECISE STREP A | Becton Dickinson Advanced Diagnostics | 1992-09-28 | 68 | 0 |
| K923060 | IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY | Becton Dickinson Advanced Diagnostics | 1992-09-15 | 82 | 0 |
| K914958 | RIATRAC PLUS | Becton Dickinson Advanced Diagnostics | 1992-03-18 | 134 | 0 |
| K915197 | PRECISE TM HCG | Becton Dickinson Advanced Diagnostics | 1991-12-17 | 28 | 0 |
| K915200 | PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA | Becton Dickinson Advanced Diagnostics | 1991-12-16 | 27 | 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