FDA 510(k)

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair

N.º K: K210212 · 2021-12-15

Fecha de decisión2021-12-15

Código de productoLAF

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del dispositivo

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines 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 2021-12-15 under 510(k) number K210212. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Psychemedics Corporation. The 510(k) number is K210212.

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

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair received FDA 510(k) clearance on 2021-12-15, under 510(k) number K210212.

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

The FDA product code for Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair is LAF.

Ensayos clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Psychemedics Corporation como solicitante

K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine 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: LAF)

K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation K201442Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersDiatron Group K170222Rapid Tox Cup IIAmerican Bio Medica Corp.K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation

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.