FDA 510(k)

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair

Número K: K201228 · 2021-06-25

Data da decisão2021-06-25

Código do produtoJXO

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine 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 2021-06-25 under 510(k) number K201228. The device is classified under product code JXO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair?

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Psychemedics Corporation. The 510(k) number is K201228.

When did Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair receive FDA 510(k) clearance?

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair received FDA 510(k) clearance on 2021-06-25, under 510(k) number K201228.

Who is the listed applicant for Psychemedics Homogeneous Enzyme Immunoassay for Cocaine 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 Homogeneous Enzyme Immunoassay for Cocaine in Hair?

The FDA product code for Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair is JXO.

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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 K192517Psychemedics Microplate EIA for Cotinine in Hair K182103Psychemedics Microplate EIA for Fentanyl in Hair K163590Psychemedics Microplate EIA for Benzodiazepines in Hair

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