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FDA 510(k)

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair

K-Number: K212952 · 2022-04-18

ApplicantPsychemedics Corporation
Decision Date2022-04-18
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair is a medical device manufactured by Psychemedics Corporation. It received FDA 510(k) clearance on 2022-04-18 under approval number K212952. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Psychemedics Corporation. The 510(k) number is K212952.

When was Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair approved by the FDA?

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

What company makes Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair?

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair is manufactured by Psychemedics Corporation.

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.

Other Devices by Psychemedics Corporation

K163590Psychemedics Microplate EIA for Benzodiazepines in Hair K182103Psychemedics Microplate EIA for Fentanyl in Hair K192517Psychemedics Microplate EIA for Cotinine 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 K201228Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair

View all 7 devices →

Related Devices (Code: LCM)

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

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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