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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 the device name listed in this FDA 510(k) record. The listed applicant is Psychemedics Corporation. It received FDA 510(k) clearance on 2020-04-22 under 510(k) 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. The listed applicant is Psychemedics Corporation. The 510(k) number is K192517.

When did Psychemedics Microplate EIA for Cotinine in Hair receive FDA 510(k) clearance?

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

Who is the listed applicant for Psychemedics Microplate EIA for Cotinine 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 Microplate EIA for Cotinine in Hair?

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

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 HairK201228Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairK182103Psychemedics Microplate EIA for Fentanyl in HairK163590Psychemedics Microplate EIA for Benzodiazepines in Hair

View all 7 devices →

Related Devices (Code: MKU)

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.

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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