Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair

K-Number: K210212 · 2021-12-15

ApplicantPsychemedics Corporation
Decision Date2021-12-15
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair is the device name listed in this FDA 510(k) record. The listed applicant is Psychemedics Corporation. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K210212. 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 Homogeneous Enzyme Immunoassay for Amphetamines in Hair?

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Psychemedics Corporation. The 510(k) number is K210212.

When did Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair receive FDA 510(k) clearance?

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair received FDA 510(k) clearance on 2021-12-15, under 510(k) number K210212.

Who is the listed applicant for Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair?

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

What is the FDA product code for Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair?

The FDA product code for Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair is LAF.

Other records listing Psychemedics Corporation 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.

K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairK201326Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in HairK201228Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairK192517Psychemedics Microplate EIA for Cotinine in HairK182103Psychemedics Microplate EIA for Fentanyl in HairK163590Psychemedics Microplate EIA for Benzodiazepines in Hair

View all 7 devices →

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 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 Corporation

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.

↑