FDA 510(k)

Psychemedics Microplate EIA for Benzodiazepines in Hair

K-Number: K163590 · 2017-09-15

Decision Date2017-09-15

Product CodeJXM

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

Psychemedics Microplate EIA for Benzodiazepines in Hair is a medical device manufactured by Psychemedics Corporation. It received FDA 510(k) clearance on 2017-09-15 under approval number K163590. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Psychemedics Microplate EIA for Benzodiazepines in Hair?

Psychemedics Microplate EIA for Benzodiazepines in Hair is a medical device that received FDA 510(k) clearance on 2017-09-15. It is manufactured by Psychemedics Corporation. The 510(k) number is K163590.

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

Psychemedics Microplate EIA for Benzodiazepines in Hair received FDA 510(k) clearance on 2017-09-15, under approval number K163590.

What company makes Psychemedics Microplate EIA for Benzodiazepines in Hair?

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

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

The FDA product code for Psychemedics Microplate EIA for Benzodiazepines in Hair is JXM.

Other Devices by Psychemedics Corporation

K182103Psychemedics Microplate EIA for Fentanyl 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

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Related Devices (Code: JXM)

K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC K173963DRI Benzodiazepine AssayMicrogenics Corporation K190968CEDIA Benzodiazepine AssayMicrogenics Corporation K221765ONLINE DAT Benzodiazepines IIRoche Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.