FDA 510(k) Applications for Medical Device Product Code "GIM"
(Tubes, Vacuum Sample, With Anticoagulant)

FDA 510(k) Number Applicant Device Name Decision Date
K213670 Becton Dickinson and Company BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes 08/25/2023
K971449 BECTON DICKINSON VACUTAINER SYSTEMS VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) 06/17/1997
K162723 Caltag Medsystems Ltd. TransFix/EDTA Vacuum Blood Collection Tubes 06/22/2017
K012152 DREW SCIENTIFIC LTD. DS30 HCY BLOOD COLLECTION TUBES 09/18/2001
K971221 GREINER AMERICA, INC. GREINER VACUETTE BLOOD COLLECTION TUBE 05/02/1997
K080552 Streck CYTO-CHEX BCT 07/31/2008


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