Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nano-Ditech Corporation — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
180 daysmedian FDA review time
272 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252283 | Nano-Check Influenza A+B Test | Nano-Ditech Corporation | 2026-01-15 | 177 | 0 |
| K243561 | Nano-Check Influenza+COVID-19 Dual Test | Nano-Ditech Corporation | 2025-06-17 | 211 | 0 |
| K240280 | Nano-Check™ RSV Test | Nano-Ditech Corporation | 2024-07-30 | 180 | 0 |
| K231187 | Nano-Check™ COVID-19 Antigen Test | Nano-Ditech Corporation | 2024-01-23 | 272 | 0 |
| K102441 | NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN | Nano-Ditech Corporation | 2010-10-20 | 83 | 0 |
| K102131 | NANO-CHECK AMI CTNI CARDIAC MARKER TEST | Nano-Ditech Corporation | 2010-10-20 | 83 | 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