The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Fetal Hemoglobin Assay.
| Device ID | BK110067 |
| 510k Number | BK110067 |
| Device Name: | Fetal Hemoglobin Assay |
| Classification | Test, Screening, For D Positive Fetal Rbc's |
| Applicant | Immucor, Inc. 3130 Gateway Drive p.o. Box 5625 Norcross, GA 30091 |
| Product Code | LIM |
| CFR Regulation Number | 864.7455 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2012-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234000907 | BK110067 | 0 |