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FDA 510(k)

PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE

K-Number: K130811 · 2013-05-02

ApplicantPsychemedics Corp.
Decision Date2013-05-02
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE is the device name listed in this FDA 510(k) record. The listed applicant is Psychemedics Corp.. It received FDA 510(k) clearance on 2013-05-02 under 510(k) number K130811. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE?

PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE is a medical device that received FDA 510(k) clearance on 2013-05-02. The listed applicant is Psychemedics Corp.. The 510(k) number is K130811.

When did PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE receive FDA 510(k) clearance?

PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE received FDA 510(k) clearance on 2013-05-02, under 510(k) number K130811.

Who is the listed applicant for PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE?

The FDA 510(k) record lists Psychemedics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE?

The FDA product code for PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE is DKZ.

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Other records listing Psychemedics Corp. 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.

K123799PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIRK111928PSYCHEMEDICS PHENCYCLIDINE EIAK111929PSYCHEMEDICS CANNABINOIDS EIAK111926PSYCHEMEDICS OPIATES EIAK111925PSYCHEMEDICS COCAINE EIAK111927PSYCHEMEDICS METHAMPHETAMINE EIA

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Related Devices (Code: DKZ)

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.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, 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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