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FDA 510(k)

PSYCHEMEDICS COCAINE EIA

K-Number: K111925 · 2012-05-01

ApplicantPsychemedics Corp.
Decision Date2012-05-01
Product CodeJXO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PSYCHEMEDICS COCAINE EIA is the device name listed in this FDA 510(k) record. The listed applicant is Psychemedics Corp.. It received FDA 510(k) clearance on 2012-05-01 under 510(k) number K111925. The device is classified under product code JXO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSYCHEMEDICS COCAINE EIA?

PSYCHEMEDICS COCAINE EIA is a medical device that received FDA 510(k) clearance on 2012-05-01. The listed applicant is Psychemedics Corp.. The 510(k) number is K111925.

When did PSYCHEMEDICS COCAINE EIA receive FDA 510(k) clearance?

PSYCHEMEDICS COCAINE EIA received FDA 510(k) clearance on 2012-05-01, under 510(k) number K111925.

Who is the listed applicant for PSYCHEMEDICS COCAINE EIA?

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 COCAINE EIA?

The FDA product code for PSYCHEMEDICS COCAINE EIA is JXO.

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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.

K130811PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINEK123799PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIRK111928PSYCHEMEDICS PHENCYCLIDINE EIAK111929PSYCHEMEDICS CANNABINOIDS EIAK111926PSYCHEMEDICS OPIATES EIAK111927PSYCHEMEDICS METHAMPHETAMINE EIA

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Related Devices (Code: JXO)

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.

K201228Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairPsychemedics CorporationK923314AUTOMATES COMA PLUS COCAINE METABOLITE ASSAYSerex, Inc.K921140STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIASolarcare Technologies Corp,Inc.K915785STC DIAGNOSTICS BENZOYLECGONINE EIASolarcare Technologies Corp,Inc.K913737IL TEST(TM) COCAINEInstrumentation Laboratory CO

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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