Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Idt, A Division of Whittaker M.A. Bioproducts · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
165 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853540 | FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY | Idt, A Division of Whittaker M.A. Bioproducts | 1986-02-04 | 165 | 0 |
| K853067 | FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT | Idt, A Division of Whittaker M.A. Bioproducts | 1985-10-22 | 92 | 0 |
| K782041 | FIAX TEST KIT | Idt, A Division of Whittaker M.A. Bioproducts | 1979-01-03 | 27 | 0 |
| K772219 | FIAX TEST FOR ANTI-RUBELLA ANTIBODY | Idt, A Division of Whittaker M.A. Bioproducts | 1978-01-20 | 46 | 0 |
| K772114 | FIAX C4 ASSAY | Idt, A Division of Whittaker M.A. Bioproducts | 1977-11-30 | 23 | 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