Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Drg Intl., Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062534 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROX | Drg Intl., Inc. | 2008-01-29 | 518 | 0 |
| K052649 | DRG SLV TESTOSTERONE ELISA TEST | Drg Intl., Inc. | 2006-01-27 | 123 | 1 |
| K051733 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL | Drg Intl., Inc. | 2005-12-07 | 162 | 0 |
| K000043 | DRG AURICA ELISA TESTOSTERONE KIT | Drg Intl., Inc. | 2000-04-17 | 102 | 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