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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 Drive
Monroe,  NC  28110
Applicant Contact Manfred Abel
Correspondent
Greiner Bio-One NA Inc.
4238 Capital Drive
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
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