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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 K182078
Device Name MiniCollect K2E K2EDTA Tubes
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 Number862.1675
Classification Product Code
JKA  
Date Received08/02/2018
Decision Date 01/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
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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