PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR— 510(k) K123799

Name: FDA 510(k) clearance K123799
Creator: U.S. Food and Drug Administration
Published: 2013-02-08

Substantially Equivalent

Psychemedics Corp.

FDA 510(k) clearance K123799 for PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR, Substantially Equivalent on 2013-02-08. Applicant: Psychemedics Corp.. Device class: 2.

Clearance details

Applicant: Psychemedics Corp.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2012-12-10
Decision date: 2013-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DJG

view all

K252684 — Labcorp Fentanyl Urine Visual Test2026-01-29
K250741 — Evidence MultiSTAT DOA Urine MultiPlex2026-01-23
K253082 — LZI Buprenorphine II Enzyme Immunoassay2026-01-16
K252520 — SEFRIA Hydrocodone Oral Fluid2025-09-11
K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative +1 more2025-08-15

More clearances from Psychemedics Corp.

view all

K130811 — PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE2013-05-02
K111925 — PSYCHEMEDICS COCAINE EIA2012-05-01
K111926 — PSYCHEMEDICS OPIATES EIA2012-05-01
K111927 — PSYCHEMEDICS METHAMPHETAMINE EIA2012-05-01
K111928 — PSYCHEMEDICS PHENCYCLIDINE EIA2012-05-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.