Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Psychemedics Corporation · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

269 daysmedian FDA review time
434 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for PhencPsychemedics Corporation2022-04-182140
K210212Psychemedics Homogeneous Enzyme Immunoassay for AmphetaminesPsychemedics Corporation2021-12-153220
K201326Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for OpiatPsychemedics Corporation2021-07-274340
K201228Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HPsychemedics Corporation2021-06-254140
K192517Psychemedics Microplate EIA for Cotinine in HairPsychemedics Corporation2020-04-222220
K182103Psychemedics Microplate EIA for Fentanyl in HairPsychemedics Corporation2019-04-182580
K163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics Corporation2017-09-152690

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