DNA/RNA Shield SafeCollect Saliva Collection kit— 510(k) K231013

Name: FDA 510(k) clearance K231013
Creator: U.S. Food and Drug Administration
Published: 2023-09-28

Substantially Equivalent

Zymo Research

FDA 510(k) clearance K231013 for DNA/RNA Shield SafeCollect Saliva Collection kit, Substantially Equivalent on 2023-09-28. Applicant: Zymo Research. Device class: 2.

Clearance details

Applicant: Zymo Research
Product code: Code QBD
Device class: Class 2
Regulation: 21 CFR 866.2950
Advisory panel: Microbiology
Date received: 2023-04-10
Decision date: 2023-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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