Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genzyme Diagnostics — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
179 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043385 | OSOM HCG COMBO TEST | Genzyme Diagnostics | 2005-04-12 | 124 | 0 |
| K983399 | GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY | Genzyme Diagnostics | 1999-01-11 | 105 | 2 |
| K963425 | GENZYME DIAGNOSTICS CONTRAST MONO | Genzyme Diagnostics | 1997-02-25 | 179 | 0 |
| K964156 | CONTRAST STRIP HCG | Genzyme Diagnostics | 1996-11-25 | 40 | 0 |
| K964155 | CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST | Genzyme Diagnostics | 1996-11-25 | 40 | 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