Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Psychemedics Microplate EIA for Fentanyl in Hair

K-Number: K182103 · 2019-04-18

ApplicantPsychemedics Corporation
Decision Date2019-04-18
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Psychemedics Microplate EIA for Fentanyl in Hair is a medical device manufactured by Psychemedics Corporation. It received FDA 510(k) clearance on 2019-04-18 under approval number K182103. 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 Microplate EIA for Fentanyl in Hair?

Psychemedics Microplate EIA for Fentanyl in Hair is a medical device that received FDA 510(k) clearance on 2019-04-18. It is manufactured by Psychemedics Corporation. The 510(k) number is K182103.

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

Psychemedics Microplate EIA for Fentanyl in Hair received FDA 510(k) clearance on 2019-04-18, under approval number K182103.

What company makes Psychemedics Microplate EIA for Fentanyl in Hair?

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

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

The FDA product code for Psychemedics Microplate EIA for Fentanyl in Hair is DJG.

Other Devices by Psychemedics Corporation

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

View all 7 devices →

Related Devices (Code: DJG)

K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 TestsChemtron Biotech, Inc. K173183CEDIA Heroin Metabolite (6-AM) AssayMicrogenics Corporation K172910Emit II Plus Oxycodone AssaySiemens Healthcare Diagnostics, Inc. K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsImmunalysis Corporation K163101CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control SetMicrogenics 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.

↑