The following data is part of a premarket notification filed by Itl Corporation, Ltd. with the FDA for Blood Bank Supplies.
Device ID | BK980008 |
510k Number | BK980008 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | ITL Corporation, LTD. 22 Molonglo Mall Fyshwick, Canberra, 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 | 1998-03-23 |
Decision Date | 1998-04-07 |