Kurin Blood Culture Collection Set With Kurin Lock Technology, Push-Button Needle (Product Models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)

Tubes, Vials, Systems, Serum Separators, Blood Collection

Kurin, Inc

The following data is part of a premarket notification filed by Kurin, Inc with the FDA for Kurin Blood Culture Collection Set With Kurin Lock Technology, Push-button Needle (product Models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223).

Pre-market Notification Details

Device IDK191832
510k NumberK191832
Device Name:Kurin Blood Culture Collection Set With Kurin Lock Technology, Push-Button Needle (Product Models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant Kurin, Inc 10840 Thornmint Road, Suite 111 San Diego,  CA  92127
ContactNeal Hartman
CorrespondentNeal Hartman
Kurin, Inc 10840 Thornmint Road, Suite 111 San Diego,  CA  92127
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-09
Decision Date2020-02-04

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