The following data is part of a premarket notification filed by Itl Corporation Pty, Ltd with the FDA for Blood Bank Supplies.
Device ID | BK030087 |
510k Number | BK030087 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | ITL Corporation Pty, Ltd 41-45 Tennant Street Canberra Act 2609, AS |
Product Code | KSS |
CFR Regulation Number | 864.9050 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-12-19 |
Decision Date | 2004-02-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
19555240400731 | BK030087 | 0 |
19555240400533 | BK030087 | 0 |
19555240403862 | BK030087 | 0 |