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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 K162233
Device Name Kurin Blood Culture Collection Set
Applicant
Pathway, LLC
8779 Cottonwood Ave. Suite 105
Santee,  CA  92071
Applicant Contact Emily Davis
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number862.1675
Classification Product Code
JKA  
Date Received08/08/2016
Decision Date 12/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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