Fetal Hemoglobin Assay

Test, Screening, For D Positive Fetal Rbc's

Immucor, Inc.

The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Fetal Hemoglobin Assay.

Pre-market Notification Details

Device IDBK110067
510k NumberBK110067
Device Name:Fetal Hemoglobin Assay
ClassificationTest, Screening, For D Positive Fetal Rbc's
Applicant Immucor, Inc. 3130 Gateway Drive p.o. Box 5625 Norcross,  GA  30091
Product CodeLIM  
CFR Regulation Number864.7455 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-21
Decision Date2012-05-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888234000907 BK110067 0

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