510(k) Report

FDA applicant

Psychemedics Corp.

Culver City, CA19 decisions2000–20220 recalls

FDA records 19 decisions for Psychemedics Corp. (Culver City, CA) from 2000 to 2022: 19 510(k) clearances. Most are in product codes DJG (Enzyme Immunoassay, Opiates) and JXO (Enzyme Immunoassay, Cocaine). Its devices cite 14 predicates, 11 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Psychemedics Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided Psychemedics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2012: 52013: 22017: 12019: 12020: 12021: 32022: 1
2007high 5 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Psychemedics Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Psychemedics Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DJGEnzyme Immunoassay, Opiates5decisions
  • JXOEnzyme Immunoassay, Cocaine2decisions
  • LAFGas Chromatography, Methamphetamine2decisions
  • LCMEnzyme Immunoassay, Phencyclidine2decisions
  • DJCThin Layer Chromatography, Methamphetamine1decision
  • LATRadioimmunoassay, Cannabinoid (S)1decision

Also: LDJ (1), DKZ (1), KLN (1), JXM (1), LCL (1), MKU (1).

Whose devices does it build on?

Its devices cite 14 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 11 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K011275Psychemedics Ria Phencyclidine AssayPsychemedics Corp. · 20022cite it
  • K123799Psychemedics Microplate Eia for Oxycodone in HairPsychemedics Corp. · 20131cites it
  • K011185Psychemedics Ria Methamphetamine and Mdma AssayPsychemedics Corp. · 20021cites it
  • K000851Psychemedics Analysis of Morphine in HairPsychemedics Corp. · 20001cites it
  • K011426Psychemedics Ria Cannabinoid AssayPsychemedics Corp. · 20021cites it
  • K111927Psychemedics Methamphetamine EiaPsychemedics Corp. · 20121cites it

What has FDA decided for it lately?

  • K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics Corporation · 2022
  • K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation · 2021
  • K201326Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme…Psychemedics Corporation · 2021
  • K201228Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairPsychemedics Corporation · 2021
  • K192517Psychemedics Microplate EIA for Cotinine in HairPsychemedics Corporation · 2020
  • K182103Psychemedics Microplate EIA for Fentanyl in HairPsychemedics Corporation · 2019
  • K163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics Corporation · 2017
  • K130811Psychemedics Microplate Eia for AmphetaminePsychemedics Corp. · 2013

All 12 as Psychemedics Corp. →All 7 as Psychemedics Corporation →