FDA 510(k)

Psychemedics Microplate EIA for Benzodiazepines in Hair

Número K: K163590 · 2017-09-15

Data da decisão2017-09-15

Código do produtoJXM

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

Psychemedics Microplate EIA for Benzodiazepines in Hair is the device name listed in this FDA 510(k) record. The listed applicant is Psychemedics Corporation. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K163590. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Psychemedics Microplate EIA for Benzodiazepines in Hair?

Psychemedics Microplate EIA for Benzodiazepines in Hair is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Psychemedics Corporation. The 510(k) number is K163590.

When did Psychemedics Microplate EIA for Benzodiazepines in Hair receive FDA 510(k) clearance?

Psychemedics Microplate EIA for Benzodiazepines in Hair received FDA 510(k) clearance on 2017-09-15, under 510(k) number K163590.

Who is the listed applicant for Psychemedics Microplate EIA for Benzodiazepines in Hair?

The FDA 510(k) record lists Psychemedics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Psychemedics Microplate EIA for Benzodiazepines in Hair?

The FDA product code for Psychemedics Microplate EIA for Benzodiazepines in Hair is JXM.

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Outros registros que listam Psychemedics Corporation como candidato(a)

K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair K201326Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair K201228Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair K192517Psychemedics Microplate EIA for Cotinine in Hair K182103Psychemedics Microplate EIA for Fentanyl in Hair

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: JXM)

K243498Kit de Reagentes para Benzodiazepínicos Alinity cMicrogenics Corporation K221765ONLINE DAT Benzodiazepines IIRoche Diagnostics K190968CEDIA Benzodiazepine AssayMicrogenics Corporation K173963DRI Benzodiazepine AssayMicrogenics Corporation K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC

Fonte oficial

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