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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 K191832
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)
Applicant
Kurin, Inc.
10840 Thornmint Rd.,
Suite 111
San Diego,  CA  92127
Applicant Contact Neal Hartman
Correspondent
Kurin, Inc.
10840 Thornmint Rd.,
Suite 111
San Diego,  CA  92127
Correspondent Contact Neal Hartman
Regulation Number862.1675
Classification Product Code
JKA  
Date Received07/09/2019
Decision Date 02/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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