FDA 510(k)

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair

N.º K: K212952 · 2022-04-18

Fecha de decisión2022-04-18

Código de productoLCM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine 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 2022-04-18 under 510(k) number K212952. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair?

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair is a medical device that received FDA 510(k) clearance on 2022-04-18. The listed applicant is Psychemedics Corporation. The 510(k) number is K212952.

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

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair received FDA 510(k) clearance on 2022-04-18, under 510(k) number K212952.

Who is the listed applicant for Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine 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 (HEIA) for Phencyclidine in Hair?

The FDA product code for Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair is LCM.

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Otros registros que enlistan a Psychemedics Corporation como solicitante

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 K163590Psychemedics Microplate EIA for Benzodiazepines in Hair

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: LCM)

K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation K181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation K163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc.

Fuente oficial

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