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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Propagating Transport
510(k) Number K202531
Device Name Azer Scientific Universal Transport Medium
Applicant
Azer Scientific, Inc.
701 Hemlock Rd.
Morgantown,  PA  19543
Applicant Contact Autumn N. Tellup
Correspondent
Azer Scientific, Inc.
44 Oxford Dr.
East Winsor,  NJ  08520
Correspondent Contact Katrina Fiedler
Regulation Number866.2390
Classification Product Code
JSM  
Date Received09/01/2020
Decision Date 04/11/2024
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
Predetermined Change
Control Plan Authorized		 No
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