FDA.report

510(k) K233979

Device
VACUETTE® QUICKSHIELD Complete (Plus)
Applicant
Greiner Bio-One North America, Inc.
510(k) number
K233979
Product code
JKA
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-19
Date received
2023-12-18
Regulation
862.1675
Classification name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Manfred Abel
Address
4238 Capital Dr. Monroe NC US 28110 28110

FDA Registration Numbers

Source Documents

510(k) summary PDF

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