FDA 510(k)

Sample Preservative Fluid

Номер K: K222771 · 2024-06-26

ЗаявительHangzhou Bioer Technology Co., Ltd.

Дата решения2024-06-26

Код продуктаQBD

Консультативный комитетMI

РешениеSubstantially Equivalent

Описание устройства

Sample Preservative Fluid is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Bioer Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-26 under 510(k) number K222771. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Sample Preservative Fluid?

Sample Preservative Fluid is a medical device that received FDA 510(k) clearance on 2024-06-26. The listed applicant is Hangzhou Bioer Technology Co., Ltd.. The 510(k) number is K222771.

When did Sample Preservative Fluid receive FDA 510(k) clearance?

Sample Preservative Fluid received FDA 510(k) clearance on 2024-06-26, under 510(k) number K222771.

Who is the listed applicant for Sample Preservative Fluid?

The FDA 510(k) record lists Hangzhou Bioer Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sample Preservative Fluid?

The FDA product code for Sample Preservative Fluid is QBD.

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: QBD)

K242820Puritan PurSafe Plus Collection and Transport SystemPuritan Medical Products, LLC K240797PPH Saliva Collection KitPermantis Public Health K233324Molecular Transport Media - MTMAlb Luz K221547InActiv BlueFertipro NV K212878Sample preservation solutionZhejiang Gene Science Co., Ltd.K231013DNA/RNA Shield SafeCollect Saliva Collection kitZymo Research

Официальный источник

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