RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054— 510(k) K080431

Name: FDA 510(k) clearance K080431
Creator: U.S. Food and Drug Administration
Published: 2009-01-08

Substantially Equivalent

Quantrx Biomedical Corporation

FDA 510(k) clearance K080431 for RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054, Substantially Equivalent on 2009-01-08. Applicant: Quantrx Biomedical Corporation. Device class: Unclassified.

Clearance details

Applicant: Quantrx Biomedical Corporation
Product code: Code LCM
Device class: Unclassified
Advisory panel: Unknown
Date received: 2008-02-19
Decision date: 2009-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCM

view all

K212952 — Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair2022-04-18
K203489 — SEFRIA PCP Oral Fluid Enzyme Immunoassay2021-04-20
K181135 — Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay2019-01-24
K163220 — Atellica CH Phencyclidine (Pcp)2017-04-06
K152176 — Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators2015-09-04

More clearances from Quantrx Biomedical Corporation

view all

K080436 — RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-00522009-02-11
K080455 — RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-00502008-12-31
K070484 — QUANTRX FEMALE FERTILITY TEST2007-10-22

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