FDA 510(k)

Immunalysis Tapentadol Urine HEIA

Номер K: K203527 · 2022-05-09

Дата решения2022-05-09

Код продуктаDJG

Консультативный комитетTX

РешениеSubstantially Equivalent

Описание устройства

Immunalysis Tapentadol Urine HEIA is the device name listed in this FDA 510(k) record. The listed applicant is Lmmunalysis Corporation. It received FDA 510(k) clearance on 2022-05-09 under 510(k) number K203527. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Immunalysis Tapentadol Urine HEIA?

Immunalysis Tapentadol Urine HEIA is a medical device that received FDA 510(k) clearance on 2022-05-09. The listed applicant is Lmmunalysis Corporation. The 510(k) number is K203527.

When did Immunalysis Tapentadol Urine HEIA receive FDA 510(k) clearance?

Immunalysis Tapentadol Urine HEIA received FDA 510(k) clearance on 2022-05-09, under 510(k) number K203527.

Who is the listed applicant for Immunalysis Tapentadol Urine HEIA?

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

What is the FDA product code for Immunalysis Tapentadol Urine HEIA?

The FDA product code for Immunalysis Tapentadol Urine HEIA is DJG.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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.

Официальный источник

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