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FDA 510(k)

PSYCHEMEDICS PHENCYCLIDINE EIA

K-Number: K111928 · 2012-05-01

ApplicantPsychemedics Corp.
Decision Date2012-05-01
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

PSYCHEMEDICS PHENCYCLIDINE 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 K111928. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSYCHEMEDICS PHENCYCLIDINE EIA?

PSYCHEMEDICS PHENCYCLIDINE 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 K111928.

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

PSYCHEMEDICS PHENCYCLIDINE EIA received FDA 510(k) clearance on 2012-05-01, under 510(k) number K111928.

Who is the listed applicant for PSYCHEMEDICS PHENCYCLIDINE 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 PHENCYCLIDINE EIA?

The FDA product code for PSYCHEMEDICS PHENCYCLIDINE EIA is LCM.

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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 EIAK111926PSYCHEMEDICS OPIATES EIAK111925PSYCHEMEDICS COCAINE EIAK111927PSYCHEMEDICS METHAMPHETAMINE EIA

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Related Devices (Code: LCM)

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 HairPsychemedics CorporationK203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc.K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEOmega Laboratories, Inc.K122703RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTORBiophor Diagnostics, 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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