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FDA 510(k)

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair

N.º K: K201228 · 2021-06-25

SolicitantePsychemedics Corporation
Fecha de decisión2021-06-25
Código de productoJXO
Comité asesorTX
DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Psychemedics Corporation como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairK210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairK201326Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in HairK192517Psychemedics Microplate EIA for Cotinine in HairK182103Psychemedics Microplate EIA for Fentanyl in HairK163590Psychemedics Microplate EIA for Benzodiazepines in Hair

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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