FDA 510(k)

Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card

Номер K: K232228 · 2024-02-23

ЗаявительShanghai Accurature Diagnostics Co., Ltd.

Дата решения2024-02-23

Код продуктаDJG

Консультативный комитетTX

РешениеSubstantially Equivalent

Описание устройства

Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Accurature Diagnostics Co., Ltd.. It received FDA 510(k) clearance on 2024-02-23 under 510(k) number K232228. 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 Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card?

Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card is a medical device that received FDA 510(k) clearance on 2024-02-23. The listed applicant is Shanghai Accurature Diagnostics Co., Ltd.. The 510(k) number is K232228.

When did Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card receive FDA 510(k) clearance?

Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card received FDA 510(k) clearance on 2024-02-23, under 510(k) number K232228.

Who is the listed applicant for Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card?

The FDA 510(k) record lists Shanghai Accurature Diagnostics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card?

The FDA product code for Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card 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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