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FDA 510(k)

Sample Preservative Fluid

K-Number: K222771 · 2024-06-26

ApplicantHangzhou Bioer Technology Co., Ltd.
Decision Date2024-06-26
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: QBD)

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.

K242820Puritan PurSafe Plus Collection and Transport SystemPuritan Medical Products, LLCK240797PPH Saliva Collection KitPermantis Public HealthK233324Molecular Transport Media - MTMAlb LuzK221547InActiv BlueFertipro NVK212878Sample preservation solutionZhejiang Gene Science Co., Ltd.K231013DNA/RNA Shield SafeCollect Saliva Collection kitZymo Research

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.

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