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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 K220677
Device Name Kurin Blood Culture Collection Set with Kurin Lock Technology
Applicant
Kurin, Inc.
10840 Thornmint Rd., Suite 111
San Diego,  CA  92012 7
Applicant Contact Neal Hartman
Correspondent
Kurin, Inc.
10840 Thornmint Rd., Suite 111
San Diego,  CA  92012 7
Correspondent Contact Neal Hartman
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FPA  
Date Received03/08/2022
Decision Date 04/28/2023
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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