The following data is part of a premarket notification filed by Nsp Tech Pte Ltd with the FDA for Blood Collection Accessory (buca).
Device ID | K181754 |
510k Number | K181754 |
Device Name: | Blood Collection Accessory (BUCA) |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | NSP Tech Pte Ltd 45A Macpherson Road Singapore, SG 348470 |
Contact | Hc Tan |
Correspondent | Hc Tan NSP Tech Pte Ltd 10 Admiralty Street Norhtlink Building, #02-06 SG 757695 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-02 |
Decision Date | 2019-07-30 |
Summary: | summary |