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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 K202641
Device Name DNA/RNA Shield Collection Tube
Zymo Research
17062 Murphy Ave.
Irvine,  CA  92614
Applicant Contact Julie Ogi
Zymo Research
17062 Murphy Ave.
Irvine,  CA  92614
Correspondent Contact Julie Ogi
Regulation Number866.2950
Classification Product Code
Date Received09/11/2020
Decision Date 12/14/2020
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