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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 K181743
Device Name Blood Transfer Accessory (BTA)
Applicant
NSP Tech Pte Ltd
45A Macpherson Road
Singapore,  SG 348470
Applicant Contact HC Tan
Correspondent
NSP Tech Pte Ltd
10 Admiralty Street
Northlink Building #02-06
SG 757695
Correspondent Contact HC Tan
Regulation Number862.1675
Classification Product Code
JKA  
Date Received07/02/2018
Decision Date 07/30/2019
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
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