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FDA 510(k)

PSYCHEMEDICS METHAMPHETAMINE EIA

K-Number: K111927 · 2012-05-01

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

Device Summary

PSYCHEMEDICS METHAMPHETAMINE 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 K111927. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSYCHEMEDICS METHAMPHETAMINE EIA?

PSYCHEMEDICS METHAMPHETAMINE 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 K111927.

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

PSYCHEMEDICS METHAMPHETAMINE EIA received FDA 510(k) clearance on 2012-05-01, under 510(k) number K111927.

Who is the listed applicant for PSYCHEMEDICS METHAMPHETAMINE 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 METHAMPHETAMINE EIA?

The FDA product code for PSYCHEMEDICS METHAMPHETAMINE EIA is LAF.

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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 EIAK111925PSYCHEMEDICS COCAINE EIA

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Related Devices (Code: LAF)

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.

K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics CorporationK201442Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersDiatron GroupK170222Rapid Tox Cup IIAmerican Bio Medica Corp.K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis CorporationK113661LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLSLin-Zhi International, 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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