The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Automated Blood Grouping And Antibody Test Systems.
| Device ID | BK070016 |
| 510k Number | BK070016 |
| Device Name: | Automated Blood Grouping And Antibody Test Systems |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | Immucor, Inc. 3130 Gateway Drive p.o. Box 5625 Norcross, GA 30091 |
| Product Code | KSZ |
| CFR Regulation Number | 864.9175 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-20 |
| Decision Date | 2007-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234001591 | BK070016 | 0 |
| 10888234001584 | BK070016 | 0 |
| 10888234001072 | BK070016 | 0 |
| 10888234001065 | BK070016 | 0 |