The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Blood Bank Supplies.
Device ID | BK890012 |
510k Number | BK890012 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | Immucor, Inc. 3130 Gateway Drive p.o. Box 5625 Norcross, GA 30091 |
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 | 1989-07-11 |
Decision Date | 1990-06-21 |