Test, Syphilis, Treponema (FOR DONOR TESTING)

Test, Donor, Syphilis, Antigens, Treponemal

Immucor, Inc.

The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Test, Syphilis, Treponema (for Donor Testing).

Pre-market Notification Details

Device IDBK120021
510k NumberBK120021
Device Name:Test, Syphilis, Treponema (FOR DONOR TESTING)
ClassificationTest, Donor, Syphilis, Antigens, Treponemal
Applicant Immucor, Inc. 3130 Gateway Drive p.o. Box 5625 Norcross,  GA  30091
Product CodeMYR  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-01
Decision Date2012-10-24

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