The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Blood Bank Supplies.
| Device ID | BK880015 |
| 510k Number | BK880015 |
| 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 | 1988-05-02 |
| Decision Date | 1988-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234000488 | BK880015 | 0 |