Test, Syphilis, Treponema (FOR DONOR TESTING)

Test, Donor, Syphilis, Antigens, Treponemal

Fujirebio Diagnostics, Inc.

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

Pre-market Notification Details

Device IDBK030007
510k NumberBK030007
Device Name:Test, Syphilis, Treponema (FOR DONOR TESTING)
ClassificationTest, Donor, Syphilis, Antigens, Treponemal
Applicant Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern,  PA  19355 US
Product CodeMYR  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-07
Decision Date2003-02-21

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