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FDA 510(k)

PSYCHEMEDICS RIA COCAINE ASSAY

K-Number: K010868 · 2001-11-06

ApplicantPsychemedics Corp.
Decision Date2001-11-06
Product CodeKLN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PSYCHEMEDICS RIA COCAINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Psychemedics Corp.. It received FDA 510(k) clearance on 2001-11-06 under 510(k) number K010868. The device is classified under product code KLN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSYCHEMEDICS RIA COCAINE ASSAY?

PSYCHEMEDICS RIA COCAINE ASSAY is a medical device that received FDA 510(k) clearance on 2001-11-06. The listed applicant is Psychemedics Corp.. The 510(k) number is K010868.

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

PSYCHEMEDICS RIA COCAINE ASSAY received FDA 510(k) clearance on 2001-11-06, under 510(k) number K010868.

Who is the listed applicant for PSYCHEMEDICS RIA COCAINE ASSAY?

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 RIA COCAINE ASSAY?

The FDA product code for PSYCHEMEDICS RIA COCAINE ASSAY is KLN.

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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 HAIRK111929PSYCHEMEDICS CANNABINOIDS EIAK111928PSYCHEMEDICS PHENCYCLIDINE EIAK111926PSYCHEMEDICS OPIATES EIAK111925PSYCHEMEDICS COCAINE EIA

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Related Devices (Code: KLN)

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.

K913867URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)Immunalysis CorporationK913722ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.K912756ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.K910122TARGET COCAINE METABOLITE-RV-Tech, Inc.K910123TARGET COCAINE METABOLITE-VV-Tech, Inc.K910044MILENIA COCAINE METABOLITEDiagnostic Products Corp.

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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