The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Kit, Quality Control For Blood Banking Reagents.
| Device ID | BK020053 |
| 510k Number | BK020053 |
| Device Name: | Kit, Quality Control 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 | 2002-11-13 |
| Decision Date | 2003-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234000600 | BK020053 | 0 |
| 10888234000594 | BK020053 | 0 |
| 10888234002307 | BK020053 | 0 |