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 |