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FDA 510(k)

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair

K-Number: K201228 · 2021-06-25

ApplicantPsychemedics Corporation
Decision Date2021-06-25
Product CodeJXO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine 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 2021-06-25 under 510(k) number K201228. The device is classified under product code JXO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Psychemedics Corporation. The 510(k) number is K201228.

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

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair received FDA 510(k) clearance on 2021-06-25, under 510(k) number K201228.

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

The FDA product code for Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair is JXO.

Other records listing Psychemedics Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairK210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairK201326Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in HairK192517Psychemedics Microplate EIA for Cotinine in HairK182103Psychemedics Microplate EIA for Fentanyl in HairK163590Psychemedics Microplate EIA for Benzodiazepines in Hair

View all 7 devices →

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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