DNA/RNA Shield SafeCollect Saliva Collection kit
K-Number: K231013 · 2023-09-28
ApplicantZymo Research
Decision Date2023-09-28
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
DNA/RNA Shield SafeCollect Saliva Collection kit is a medical device manufactured by Zymo Research. It received FDA 510(k) clearance on 2023-09-28 under approval number K231013. 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 SafeCollect Saliva Collection kit?
DNA/RNA Shield SafeCollect Saliva Collection kit is a medical device that received FDA 510(k) clearance on 2023-09-28. It is manufactured by Zymo Research. The 510(k) number is K231013.
When was DNA/RNA Shield SafeCollect Saliva Collection kit approved by the FDA?
DNA/RNA Shield SafeCollect Saliva Collection kit received FDA 510(k) clearance on 2023-09-28, under approval number K231013.
What company makes DNA/RNA Shield SafeCollect Saliva Collection kit?
DNA/RNA Shield SafeCollect Saliva Collection kit is manufactured by Zymo Research.
What is the FDA product code for DNA/RNA Shield SafeCollect Saliva Collection kit?
The FDA product code for DNA/RNA Shield SafeCollect Saliva Collection kit is QBD.
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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.