Source document or public record
FDA 510(k) K231013 — DNA/RNA Shield SafeCollect Saliva Collection kit
FDA 510(k) index record K231013. Device: DNA/RNA Shield SafeCollect Saliva Collection kit. Applicant as listed: Zymo Research. Decision date: 2023-09-28.
Source
"device_name": "DNA/RNA Shield SafeCollect Saliva Collection kit"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K231013.
Device name: DNA/RNA Shield SafeCollect Saliva Collection kit. Applicant as listed: Zymo Research.
Decision date: 2023-09-28. Decision wording: Substantially Equivalent.
Product code: QBD. Regulation: 21 CFR 866.2950. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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