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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K233979
Device Name VACUETTE® QUICKSHIELD Complete (Plus)
Applicant
Greiner Bio-One North America, Inc.
4238 Capital Dr.
Monroe,  NC  28110
Applicant Contact Manfred Abel
Correspondent
Greiner Bio-One North America, Inc.
4238 Capital Dr.
Monroe,  NC  28110
Correspondent Contact Manfred Abel
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FMI  
Date Received12/18/2023
Decision Date 07/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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