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

Psychemedics Corp. — Predicate Candidate Screening

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

300 daysmedian FDA review time
300 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K130811PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINEPsychemedics Corp.2013-05-02380
K123799PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIRPsychemedics Corp.2013-02-08600
K111928PSYCHEMEDICS PHENCYCLIDINE EIAPsychemedics Corp.2012-05-013000
K111927PSYCHEMEDICS METHAMPHETAMINE EIAPsychemedics Corp.2012-05-013000
K111925PSYCHEMEDICS COCAINE EIAPsychemedics Corp.2012-05-013000
K111929PSYCHEMEDICS CANNABINOIDS EIAPsychemedics Corp.2012-05-013000
K111926PSYCHEMEDICS OPIATES EIAPsychemedics Corp.2012-05-013000
K011426PSYCHEMEDICS RIA CANNABINOID ASSAYPsychemedics Corp.2002-05-033600
K011275PSYCHEMEDICS RIA PHENCYCLIDINE ASSAYPsychemedics Corp.2002-02-112910
K011185PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAYPsychemedics Corp.2002-01-242810
K010868PSYCHEMEDICS RIA COCAINE ASSAYPsychemedics Corp.2001-11-062280
K000851PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIRPsychemedics Corp.2000-12-112710

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