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FDA 510(k)

Psychemedics Microplate EIA for Cotinine in Hair

K-Number: K192517 · 2020-04-22

ApplicantPsychemedics Corporation
Decision Date2020-04-22
Product CodeMKU
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Psychemedics Microplate EIA for Cotinine in Hair is a medical device manufactured by Psychemedics Corporation. It received FDA 510(k) clearance on 2020-04-22 under approval number K192517. The device is classified under product code MKU. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Psychemedics Microplate EIA for Cotinine in Hair?

Psychemedics Microplate EIA for Cotinine in Hair is a medical device that received FDA 510(k) clearance on 2020-04-22. It is manufactured by Psychemedics Corporation. The 510(k) number is K192517.

When was Psychemedics Microplate EIA for Cotinine in Hair approved by the FDA?

Psychemedics Microplate EIA for Cotinine in Hair received FDA 510(k) clearance on 2020-04-22, under approval number K192517.

What company makes Psychemedics Microplate EIA for Cotinine in Hair?

Psychemedics Microplate EIA for Cotinine in Hair is manufactured by Psychemedics Corporation.

What is the FDA product code for Psychemedics Microplate EIA for Cotinine in Hair?

The FDA product code for Psychemedics Microplate EIA for Cotinine in Hair is MKU.

Other Devices by Psychemedics Corporation

K163590Psychemedics Microplate EIA for Benzodiazepines in Hair K182103Psychemedics Microplate EIA for Fentanyl 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 K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair

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Related Devices (Code: MKU)

K192299LZI Cotinine II Enzyme ImmunoassayLin-Zhi International, Inc.

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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