Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quest Diagnostics, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
201 daysmedian FDA review time
335 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080381 | QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA | Quest Diagnostics, Inc. | 2008-06-25 | 133 | 0 |
| K062929 | QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA | Quest Diagnostics, Inc. | 2006-12-18 | 81 | 0 |
| K051161 | QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) | Quest Diagnostics, Inc. | 2005-11-22 | 201 | 0 |
| K042726 | QUEST DIAGNOSTICS HAIRCHECK-DT (PCP | Quest Diagnostics, Inc. | 2005-07-28 | 300 | 0 |
| K042725 | QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) | Quest Diagnostics, Inc. | 2005-07-06 | 278 | 0 |
| K040257 | QUEST DIAGNOSTICS HAIRCHECK-DT (THC) | Quest Diagnostics, Inc. | 2004-06-14 | 131 | 0 |
| K023626 | AML HAIRCHECK-DT (COCAINE) | Quest Diagnostics, Inc. | 2003-09-29 | 335 | 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