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FDA 510(k)

Sample preservation solution

K-Number: K212878 · 2024-04-08

Decision Date2024-04-08
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Sample preservation solution is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Gene Science Co., Ltd.. It received FDA 510(k) clearance on 2024-04-08 under 510(k) number K212878. 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 preservation solution?

Sample preservation solution is a medical device that received FDA 510(k) clearance on 2024-04-08. The listed applicant is Zhejiang Gene Science Co., Ltd.. The 510(k) number is K212878.

When did Sample preservation solution receive FDA 510(k) clearance?

Sample preservation solution received FDA 510(k) clearance on 2024-04-08, under 510(k) number K212878.

Who is the listed applicant for Sample preservation solution?

The FDA 510(k) record lists Zhejiang Gene Science Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sample preservation solution?

The FDA product code for Sample preservation solution is QBD.

Related Clinical Trials

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.

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.

Official Source

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