FDA 510(k)

Psychemedics Microplate EIA for Fentanyl in Hair

N.º K: K182103 · 2019-04-18

Fecha de decisión2019-04-18

Código de productoDJG

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del dispositivo

Psychemedics Microplate EIA for Fentanyl 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 2019-04-18 under 510(k) number K182103. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Psychemedics Microplate EIA for Fentanyl in Hair?

Psychemedics Microplate EIA for Fentanyl in Hair is a medical device that received FDA 510(k) clearance on 2019-04-18. The listed applicant is Psychemedics Corporation. The 510(k) number is K182103.

When did Psychemedics Microplate EIA for Fentanyl in Hair receive FDA 510(k) clearance?

Psychemedics Microplate EIA for Fentanyl in Hair received FDA 510(k) clearance on 2019-04-18, under 510(k) number K182103.

Who is the listed applicant for Psychemedics Microplate EIA for Fentanyl 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 Microplate EIA for Fentanyl in Hair?

The FDA product code for Psychemedics Microplate EIA for Fentanyl in Hair is DJG.

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Otros registros que enlistan a Psychemedics Corporation como solicitante

K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair K201326Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair K201228Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair K192517Psychemedics Microplate EIA for Cotinine in Hair K163590Psychemedics Microplate EIA for Benzodiazepines in Hair

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: DJG)

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited K253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLC K251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

Fuente oficial

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