FDA 510(k)

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair

Número K: K212952 · 2022-04-18

Data da decisão2022-04-18

Código do produtoLCM

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Psychemedics Corporation como candidato(a)

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 os 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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.