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510(k) K220908

Ensol EnTM Specimen Collection and Transport System by Ensol Biosciences, Inc. — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2024
Date Received
March 29, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type

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