Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Seracare Technology · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
100 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993631 | QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 | Seracare Technology | 1999-12-09 | 43 | 0 |
| K992939 | QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 | Seracare Technology | 1999-12-09 | 100 | 0 |
| K993715 | QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 | Seracare Technology | 1999-11-16 | 13 | 0 |
| K992770 | QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3 | Seracare Technology | 1999-11-12 | 87 | 0 |
| K992395 | URINE DRUG SCREENING CONTROL | Seracare Technology | 1999-08-26 | 38 | 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