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FDA 510(k) Application Details - K182078
Device Classification Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
More FDA Info for this Device
510(K) Number
K182078
Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant
Greiner Bio-One NA Inc.
4238 Capital Drive
Monroe, NC 28110 US
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Contact
Manfred Abel
Other 510(k) Applications for this Contact
Regulation Number
862.1675
More FDA Info for this Regulation Number
Classification Product Code
JKA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/02/2018
Decision Date
01/25/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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