The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Quality Control Kits For Blood Banking Reagents.
| Device ID | BK040010 |
| 510k Number | BK040010 |
| Device Name: | Quality Control Kits For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | Immucor, Inc. 3130 Gateway Drive p.o. Box 5625 Norcross, GA 30091 |
| Product Code | KSF |
| CFR Regulation Number | 864.9650 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-03 |
| Decision Date | 2004-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234002178 | BK040010 | 0 |
| 10888234001089 | BK040010 | 0 |