The following data is part of a premarket notification filed by Indico, Inc. with the FDA for Blood Bank Supplies.
Device ID | BK000008 |
510k Number | BK000008 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | Indico, Inc. suite 137 6325 103 Street Edmonton, ALBERTA, T6H 5H6, CA |
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 | 2000-02-04 |
Decision Date | 2000-03-01 |