Documento fuente o registro público

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.

OtherU.S. Food and Drug Administration (FDA)2023-09-28

Fuente

"device_name": "DNA/RNA Shield SafeCollect Saliva Collection kit"

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-28

Disclaimer

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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