Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immuno-Diagnostic Products, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
204 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K854207 | EBV(EPSTEIN-BARR VIRUS) TEST KIT | Immuno-Diagnostic Products, Inc. | 1986-04-24 | 190 | 0 |
| K811021 | HERPES | Immuno-Diagnostic Products, Inc. | 1981-11-05 | 204 | 0 |
| K811562 | TOXOPLASMOSIS TEST KIT | Immuno-Diagnostic Products, Inc. | 1981-07-16 | 43 | 0 |
| K811022 | ANA TEST KIT | Immuno-Diagnostic Products, Inc. | 1981-04-23 | 8 | 0 |
| K801959 | FTA-ABS TEST | Immuno-Diagnostic Products, Inc. | 1980-10-23 | 65 | 0 |
| K801963 | CMV TEST KIT | Immuno-Diagnostic Products, Inc. | 1980-10-23 | 65 | 0 |
| K801960 | ANTI-DS/N-DNA TEST KIT | Immuno-Diagnostic Products, Inc. | 1980-10-10 | 52 | 0 |
| K801961 | RF-II TEST KIT | Immuno-Diagnostic Products, Inc. | 1980-10-10 | 52 | 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