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FDA 510(k)

Psychemedics Microplate EIA for Benzodiazepines in Hair

K-Number: K163590 · 2017-09-15

ApplicantPsychemedics Corporation
Decision Date2017-09-15
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Psychemedics Microplate EIA for Benzodiazepines 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 2017-09-15 under 510(k) 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. The listed applicant is Psychemedics Corporation. The 510(k) number is K163590.

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

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

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

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

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 HairK192517Psychemedics Microplate EIA for Cotinine in HairK182103Psychemedics Microplate EIA for Fentanyl in Hair

View all 7 devices →

Related Devices (Code: JXM)

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.

K243498Alinity c Benzodiazepines Reagent KitMicrogenics CorporationK221765ONLINE DAT Benzodiazepines IIRoche DiagnosticsK190968CEDIA Benzodiazepine AssayMicrogenics CorporationK173963DRI Benzodiazepine AssayMicrogenics CorporationK163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLCK153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC

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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