Qualitative Test For HLA, Non-diagnostic

Test, Qualitative, For Hla, Non-diagnostic

Immucor Transplant Diagnostics, Inc.

The following data is part of a premarket notification filed by Immucor Transplant Diagnostics, Inc. with the FDA for Qualitative Test For Hla, Non-diagnostic.

Pre-market Notification Details

Device IDBK150302
510k NumberBK150302
Device Name:Qualitative Test For HLA, Non-diagnostic
ClassificationTest, Qualitative, For Hla, Non-diagnostic
Applicant Immucor Transplant Diagnostics, Inc. 550 West Avenue Stamford,  CT  06902
Product CodeMZI  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-05
Decision Date2016-05-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888234400769 BK150302 0
10888234400479 BK150302 0
10888234400462 BK150302 0
10888234500827 BK150302 0

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