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Clinical Toxicology devices

180 product codes reviewed by the Clinical Toxicology panel. 3,041 510(k) clearances and 395 recalls in the FDA data, 85% of those recalls name a 510(k).

14510(k)s in 12 months
13recalls in 12 months
337recalls that name a 510(k)

Active product codes, Class II

CodeDeviceClass510(k)s, 12 moRecalls, 12 mo
NFTTest, Amphetamine, Over The Counter260
DJGEnzyme Immunoassay, Opiates232
DOFLead, Atomic Absorption205
LBZEnzyme Immunoassay, Quinidine202
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method201
DJCThin Layer Chromatography, Methamphetamine210
KLREnzyme Immunoassay, Lidocaine201
LDPColorimetry, Acetaminophen210
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs201
MXASystem, Test, Breath Nitric Oxide210
NFWTest, Cannabinoid, Over The Counter210
NGLTest, Opiates, Over The Counter210
QDRPlazomicin Test System, Immunoassay201

Other panels: Anesthesiology · Cardiovascular · Clinical Chemistry · Dental · Ear, Nose, Throat · Gastroenterology, Urology · General Hospital · General, Plastic Surgery · Hematology · Immunology · Medical Genetics · Microbiology · Neurology · Obstetrics/Gynecology · Ophthalmic · Orthopedic · Pathology · Physical Medicine · Radiology