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FDA 510(k)

DNA/RNA Shield Collection Tube

K-Number: K202641 · 2020-12-14

ApplicantZymo Research
Decision Date2020-12-14
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DNA/RNA Shield Collection Tube is the device name listed in this FDA 510(k) record. The listed applicant is Zymo Research. It received FDA 510(k) clearance on 2020-12-14 under 510(k) number K202641. 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 DNA/RNA Shield Collection Tube?

DNA/RNA Shield Collection Tube is a medical device that received FDA 510(k) clearance on 2020-12-14. The listed applicant is Zymo Research. The 510(k) number is K202641.

When did DNA/RNA Shield Collection Tube receive FDA 510(k) clearance?

DNA/RNA Shield Collection Tube received FDA 510(k) clearance on 2020-12-14, under 510(k) number K202641.

Who is the listed applicant for DNA/RNA Shield Collection Tube?

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

What is the FDA product code for DNA/RNA Shield Collection Tube?

The FDA product code for DNA/RNA Shield Collection Tube is QBD.

Other records listing Zymo Research as applicant

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.

K231013DNA/RNA Shield SafeCollect Saliva Collection kit

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 HealthK222771Sample Preservative FluidHangzhou Bioer Technology Co., Ltd.K233324Molecular Transport Media - MTMAlb LuzK221547InActiv BlueFertipro NVK212878Sample preservation solutionZhejiang Gene Science Co., Ltd.

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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