Medical Device Manufacturer · US , Cambridge , MA

Psychemedics Corp.

12 submissions · 12 cleared · Since 2000
12
Total
12
Cleared
0
Denied

Psychemedics Corp. — FDA 510(k) Submissions

Psychemedics Corp. has submitted 12 FDA 510(k) premarket notifications since 2000, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Phencyclidine, Enzyme Immunoassay, Cannabinoids, Enzyme Immunoassay, Amphetamine, Radioimmunoassay, Cocaine Metabolite . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
K130811 · DKZ Enzyme Immunoassay,... · Toxicology
May 2013 38d
PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR
K123799 · DJG Enzyme Immunoassay, Opiates · Toxicology
Feb 2013 60d
PSYCHEMEDICS COCAINE EIA
K111925 · JXO Enzyme Immunoassay, Cocaine · Toxicology
May 2012 300d
PSYCHEMEDICS OPIATES EIA
K111926 · DJG Enzyme Immunoassay, Opiates · Toxicology
May 2012 300d
PSYCHEMEDICS METHAMPHETAMINE EIA
K111927 · LAF Gas Chromatography,... · Chemistry
May 2012 300d
PSYCHEMEDICS PHENCYCLIDINE EIA
K111928 · LCM Enzyme Immunoassay,... · Chemistry
May 2012 300d
PSYCHEMEDICS CANNABINOIDS EIA
K111929 · LDJ Enzyme Immunoassay,... · Toxicology
May 2012 300d
PSYCHEMEDICS RIA CANNABINOID ASSAY
K011426 · LAT Radioimmunoassay,... · Toxicology
May 2002 360d
PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY
K011275 · LCL Radioimmunoassay,... · Toxicology
Feb 2002 291d
PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
K011185 · DJC Thin Layer... · Toxicology
Jan 2002 281d
PSYCHEMEDICS RIA COCAINE ASSAY
K010868 · KLN Radioimmunoassay, Cocaine... · Toxicology
Nov 2001 228d
PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR
K000851 · DJG Enzyme Immunoassay, Opiates · Toxicology
Dec 2000 271d
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