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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 K163436
Device Name Greiner Vacuette Urine Count and Culture, Mannitol tube
Applicant
Greiner Bio-One Na, Inc.
4238 Capital Dr.
Monroe,  NC  28110
Applicant Contact MANFRED ABEL
Correspondent
Greiner Bio-One Na, Inc.
4238 Capital Dr.
Monroe,  NC  28110
Correspondent Contact MANFRED ABEL
Regulation Number866.2390
Classification Product Code
JSM  
Subsequent Product Code
LIO  
Date Received12/07/2016
Decision Date 03/06/2017
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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