The following data is part of a premarket notification filed by Timestrip Uk Ltd. with the FDA for Blood Bank Supplies.
Device ID | BK190363 |
510k Number | BK190363 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | Timestrip UK Ltd. 22 Friars Street sudbury Suffolk, CO102AA, UK |
Product Code | KSS |
CFR Regulation Number | 864.9050 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-06-24 |
Decision Date | 2019-07-22 |