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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microbial Nucleic Acid Storage And Stabilization Device
510(k) Number K231013
Device Name DNA/RNA Shield SafeCollect Saliva Collection kit
Applicant
Zymo Research
17062 Murphy Ave
Irvine,  CA  92614
Applicant Contact Julie Ogi
Correspondent
Zymo Research
17062 Murphy Ave
Irvine,  CA  92614
Correspondent Contact Julie Ogi
Classification Product Code
QBD  
Date Received04/10/2023
Decision Date 09/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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