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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 K181754
Device Name Blood Collection Accessory (BUCA)
Applicant
Nsp Tech Pte, Ltd.
45a Macpherson Rd.
Singapore,  SG 348470
Applicant Contact HC Tan
Correspondent
Nsp Tech Pte, Ltd.
10 Admiralty St.
Norhtlink Bldg., #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
Predetermined Change
Control Plan Authorized		 No
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