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FDA 510(k)

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair

K-Number: K201326 · 2021-07-27

ApplicantPsychemedics Corporation
Decision Date2021-07-27
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair is a medical device manufactured by Psychemedics Corporation. It received FDA 510(k) clearance on 2021-07-27 under approval number K201326. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair?

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair is a medical device that received FDA 510(k) clearance on 2021-07-27. It is manufactured by Psychemedics Corporation. The 510(k) number is K201326.

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

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair received FDA 510(k) clearance on 2021-07-27, under approval number K201326.

What company makes Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair?

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair is manufactured by Psychemedics Corporation.

What is the FDA product code for Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair?

The FDA product code for Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair is DJG.

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 K201228Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair

View all 7 devices →

Related Devices (Code: DJG)

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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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